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K Number
K182679
Device Name
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
Manufacturer
Canon Medical Systems Corporation
Date Cleared
2018-10-31

(35 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are indication of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediat, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.
Device Description
The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600, V3.1 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 30 MHz.
More Information

K173090, K172607, K172342

K172607, K172342

No
The document does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML applications in medical imaging. The performance studies focus on image processing features and measurements, not AI-driven analysis or interpretation.

No
The device is described as a "Diagnostic Ultrasound System" intended for "indication of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis." Its purpose is to provide "image information for diagnosis," not to treat conditions.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the systems "provide image information for diagnosis in the following clinical applications." The "Device Description" also refers to the systems as "mobile diagnostic ultrasound systems."

No

The device description explicitly states it is a "mobile diagnostic ultrasound system" and mentions employing "a wide array of probes," which are hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is used to "provide image information for diagnosis in the following clinical applications" using ultrasound. This describes a device that images structures and processes within the human body.
  • Device Description: The description confirms it's a "mobile diagnostic ultrasound system." Ultrasound systems work by transmitting sound waves into the body and receiving the reflected echoes to create images.
  • Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside the body to obtain information about a person's health. There is no mention of analyzing biological samples in the provided text.

Therefore, this device is a diagnostic imaging system, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are indication of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediat, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600, V3.1 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 30 MHz.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic. Additional entries per transducer: Ophthalmic, Laparoscopic, Trans-vaginal, Trans-urethral, Peripheral vessel. Small organ includes thyroid, breast and testicle.

Indicated Patient Age Range

Adult and Pediatric (including fetal and neonatal)

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Performance Testing - Assessment of Limb Volume Measurement
(I) New growth predictor of Fractional limb volume (Fractional arm volume (AVol), Fractional thigh volume (TVol)) are correctly calculated using the test data phantom and in a clinical evaluation
(II) Estimated fetal weight (EFW) is correctly calculated using either the new growth predictor above or in combination with the existing growth predictor (such as abdominal circumference (AC), head circumference (HC), biparietal diameter (BPD), and femur length (FL) using the clinical data)

Performance Testing - Assessment of Contrast Vector Imaging
(I) the color mapping image is depicted correctly in terms of the spatial distribution of the moving bubble including Arrival time, Direction, Velocity, Direction-Center, etc. using a wire phantom and test data
(II) quantitative measurement results (Velocity and Direction) are obtained correctly using a string phantom, a flow phantom and test data

Performance Testing - Assessment of Breast Scan Guide
(I) the subject device correctly displays the locational information of an object of interest in the Xray image received from a mammography system. More specifically, the location information of the breast body mark in the ultrasound system matches with the lines calculated using the locational data directly obtained from X-ray image

Additional performance testing, using phantom and volunteer studies, was conducted to assess improvements to existing features including 3D Wall Motion Tracking, 2D Wall Motion Tracking, Smart Fusion and 2nd Console.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Risk Analysis, Verification/Validation testing conducted through bench testing and clinical evaluation which are included in this submission demonstrates that the requirements for the new and improved features have been met.
Performance Testing - Assessment of Limb Volume Measurement: The primary objective of this study confirmed that Limb Volume Measurement is substantially equivalent to the predicate device with regard to: (I) New growth predictor of Fractional limb volume (Fractional arm volume (AVol), Fractional thigh volume (TVol)) are correctly calculated using the test data phantom and in a clinical evaluation (II) Estimated fetal weight (EFW) is correctly calculated using either the new growth predictor above or in combination with the existing growth predictor (such as abdominal circumference (AC), head circumference (HC), biparietal diameter (BPD), and femur length (FL) using the clinical data).
Performance Testing - Assessment of Contrast Vector Imaging: The primary objective of this study confirmed that this feature is substantially equivalent to the predicate device with regard to: (I) the color mapping image is depicted correctly in terms of the spatial distribution of the moving bubble including Arrival time, Direction, Velocity, Direction-Center, etc. using a wire phantom and test data (II) quantitative measurement results (Velocity and Direction) are obtained correctly using a string phantom, a flow phantom and test data.
Performance Testing - Assessment of Breast Scan Guide: The primary objective of this study confirmed that this feature is substantially equivalent to the predicate device with regard to: (I) the subject device correctly displays the locational information of an object of interest in the Xray image received from a mammography system. More specifically, the location information of the breast body mark in the ultrasound system matches with the lines calculated using the locational data directly obtained from X-ray image.
Additional performance testing, using phantom and volunteer studies, was conducted to assess improvements to existing features including 3D Wall Motion Tracking, 2D Wall Motion Tracking, Smart Fusion and 2nd Console. Results of all these studies demonstrated that the improvements met specifications and performed as intended.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K173090, K172607, K172342

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K172607, K172342

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Canon Medical Systems Corporation % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO, MN 55313

October 31, 2018

Re: K182679

Trade/Device Name: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 26, 2018 Received: October 30, 2018

Dear Mark Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. Digitally signed by Date: 2018.10.31 For O'hara -S 15:52:07 -04'00' Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K182679

Device Name

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1

Indications for Use (Describe)

The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are indication of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediat, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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3

Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor DopplerPrecision Imaging
Combined (Specify)Apli PureMicro PureBEAMPowerTDIElastographySMI(ADF)Shear wave4D3D Color
(Volume color)STICSTIC ColorFusionSmart Navigation2D WMTOther
[Note]
Ophthalmic
FetalPPPP2PPPNPPPPPPN6,8
AbdominalPPPPP2,3PPPPPPPPPPPP4,5,6,7,8
Intra-operative (Abdominal)PPPP2PPPPP
Intra-operative (Neuro)
LaparoscopicPPPP2PPPPP
PediatricPPPPP2,3PPPPPPPPPPP6,8
Small Organ (Note 1)PPPP2PPPPPPPPPP6
Neonatal CephalicPPPPP3PP
Adult CephalicPPPPP3NPPPP6,
Trans-rectalPPPP2PPPPPPPPPP8
Trans-vaginalPPPP2PPPPPPPPPP8
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)PPPP2PPPPPPPPPP6,8(N)
Musculo-skeletal (Superficial)PPPP2PPPPPPPPPP6,8(N)
Intravascular
Other (Specify)
Cardiac AdultPPPPP3PPPPPPP7,8,9,10
Cardiac PediatricPPPPP3PPPPPP7,8,9,10
Intravascular (Cardiac)
Trans-esoph. (Cardiac)PPPPP3PPPPP8,10,11
Intra-cardiac
Other (Specify)
Peripheral vesselPPPPP2PPPPPPPPPP6
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

4

Transducer: PSI-28BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of OperationOther [Note]
Specific
(Tracks 3)BMPWDCWDColor DopplerPrecision Imaging
Combined (Specify) *Apli PureMicro PureBEAMPowerTDIElastographySMI(ADF)Shear wave4D
(Volume color)3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther [Note]
Ophthalmic
Fetal
AbdominalNNNNN3NNNNN6(N),7(N),8(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal CephalicNNNNN3NNN
Adult CephalicNNNNN3NNNNN6(N)
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultNNNNN3NNNNN7(N),8(N)
Cardiac PediatricNNNNN3NNNN7(N),8(N)
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: N/A Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

  • Note 4 ATI
  • Note 5 Tissue Intensity Analysis
  • Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

5

Transducer: PSI-30BX

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of OperationOther [Note]
Specific
(Tracks 3)BMPWDCWDColor DopplerPrecision Imaging
Combined (Specify) *Apli PureMicro PureBEAMPowerTDIElastographyShear waveSMI(ADF)4D
(Volume color)3D ColorSTICSTIC ColorSmart 3DFusionSmart Navigation2D WMT
Ophthalmic
Fetal
AbdominalPPPPP3PPPPP6(P)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP3PPPPP6(P)
Small Organ (Note 1)
Neonatal CephalicPPPPP3PPP
Adult CephalicPPPPP3NPPP6(P)
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultPPPPP3PPPPPP7
Cardiac PediatricPPPPP3PPPPPP7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

6

Transducer: PSI-70BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|---------------------------------|---|---|-----|-----|---------------|----------------------|-------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | | | | P | | | P | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | | | | P | | | P | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | | | | P | | | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | | | | | P | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | | | | P | P | | | | | | | | | | | P 7 | | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | | | | P | P | | | | | | | | | | | P 7 | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)Note8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

7

Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of OperationOtherNote
Specific
(Tracks 3)BMPWDCWDColor DopplerPrecision Imaging
Combined (Specify) *Apli PureMicro PureBEAMPowerTDIElastographyShear wave
SMI(ADF)4D
(Volume color)3D ColorSTICSTIC ColorSmart 3DFusionSmart Navigation2D WMT
Ophthalmic
Fetal
AbdominalPPPPP3PPP
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP3PPP
Small Organ (Note 1)
Neonatal CephalicPPPPP3PPP
Adult CephalicPPPPP3NPP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultPPPPP3PPPP
Cardiac PediatricPPPPP3PPPP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

8

PST-30BT Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Op
----------------------------------

| Clinical Application
Specific

(Tracks 3)Mode of Operation
BMPWDCWDColor DopplerCombined (Specify) *Precision ImagingMicro PureApli PureBEAMPowerTDIElastographyShear wave
SMI(ADF)4D
(Volume color)3D ColorSTICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther
[Note]
Ophthalmic
Fetal
AbdominalPPPPP3PPP7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP3PPP
Small Organ (Note 1)
Neonatal CephalicPPPPP3P
Adult CephalicPPPPP3NP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultPPPPP3PPP7
Cardiac PediatricPPPPP3PPP7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

9

PST-50BT Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation Clinical Application

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|------------------------|---|-----|-----|---------------|----------------------|-------------------|------------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | | | P | | P | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | | | P | | P | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | | | | P | | | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | | | | P | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | | | | P | P | | | | | | | | | | P | | | |
| Cardiac Pediatric | P | P | P | P | P | 3 | | | | P | P | | | | | | | | | | P | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

10

PSI-30VX Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Apli Pure
Precision Imaging
Combined (Specify) * | Micro Pure
BEAM | Power | TDI | Elastography | SMI(ADF)
Shear wave | 4D
(Volume color)
3D Color | STIC | STIC Color | Smart 3D | Fusion
Smart Navigation | 2D WMT | Other
[Note] |
|------------------------------------------------|---|---|-----|-----|---------------|--------------------------------------------------------|--------------------|-------|-----|--------------|------------------------|----------------------------------|------|------------|----------|----------------------------|--------|-----------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 P | | P | | | P | P | | P | P | P | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 P | | P | | | P | P | | P | P | P | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 P | | P | | | P | | | P | | P | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 P | | P | P | | P | P | | | | | P | 7,8,9,10 |
| Cardiac Pediatric | P | P | P | P | P | 3 P | | P | P | | P | P | | | | | P | 7,8,9,10 |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers:K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BD/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

11

PSI-40VX Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color Doppler | Combined (Specify) *
Precision Imaging | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
|------------------------------------------------|-------------------|---|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|--------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | P | P | P | | P | 2 | | | | P | | | P | | P | P | | | | | | | |
| Abdominal | | P | P | P | P | P | 3 | P | | | P | | | P | | P | P | | | | P | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | 3 | P | | | P | | | P | | P | P | | | | P | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | P | P | P | P | P | 3 | P | | | P | P | | | | P | P | | | | | | P | 7,8,9,10 |
| Cardiac Pediatric | | P | P | P | P | P | 3 | P | | | P | P | | | | P | P | | | | | | P | 7,8,9,10 |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BD/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

12

PSI-50VX Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
|------------------------------------------------|-------------------|---|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|--------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | 2 | | | | P | | | P | | P | P | | | | | | | |
| Abdominal | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | 3 | P | | | P | | | P | | P | P | | | P | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | P | P | P | P | P | 3 | P | | | P | P | | | | P | P | | | | | | P | 7,8,9,10 |
| Cardiac Pediatric | | P | P | P | P | P | 3 | P | | | P | P | | | | P | P | | | | | | P | 7,8,9,10 |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BD/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

13

Transducer: PVI-475BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | Color Doppler | CWD | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
|------------------------------------------------|---|---|-----|---------------|-----|-------------------------------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|--------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | P | 2 | P | P | | | P | N | | P | | | | P | | | | | | |
| Abdominal | P | P | P | P | 2 | P | P | | | P | P | P | P | P | P | | P | P | P | P | P | | 6,7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | 2 | P | P | | | P | | | P | | | | P | P | P | P | P | | 6 |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

14

Transducer: PVI-475BX

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Apli Pure | Micro Pure | Power
BEAM | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
|------------------------------------------------|---|---|-----|-----|---------------|----------------------|-------------------|-----------|------------|---------------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|--------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | P | N | P | | P | | | | P | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | P | P | P | P | P | P | P | | P | P | P | P | | 4,5,6,7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | P | P | | | | P | | | | P | P | P | | 6 |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal(Conventional) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

15

Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D
(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|------------------------|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----------------------|----------|------|------------|----------|--------|------------------|--------|----------------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | N | N | N | | N | N | N | N | | N | N | | N | | | | | | N | | | N | 6(N), 8(N) | |
| Abdominal | N | N | N | | N | N | N | N | | N | | | N | N | | | | | N | N | N | | 6(N),7(N),8(N) | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | N | | N | | | N | | | | | | N | N | N | | 6(N),8(N) | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers:N/A Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

16

Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D
(Volume color) | 4D | STIC Color | STIC | Smart 3D | Smart Navigation | 2D WMT | Other
[Note] | | |
|------------------------------------------------|------------------------|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----------------------|----|------------|------|----------|------------------|--------|-----------------|----------------|-----------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | N | N | N | | N | 2 | N | N | | N | N | | N | | | | | | N | | N | 6(N), 8(N) | | |
| Abdominal | N | N | N | N | N | 2 | N | N | | N | | | N | N | | | | | N | N | N | | 6(N),7(N),8(N) | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | N | N | N | | N | 2 | N | N | | N | | | N | | | | | | | N | N | N | | 6(N),8(N) |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers:N/A Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

17

Transducer: PVT-482BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D
(Volume color) | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|---|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----------------------|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | | P | | | P | | | | | | P | | | | | 6 |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | P | | | | | | P | P | P | | | 6,7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | | P | | | P | | | | | | P | P | P | | | 6 |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

18

PVT-375BT Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application | Mode of Operation

| Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler
Combined (Specify) * | Precision Imaging | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D
(Volume color) | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
|-------------------------------------|---|---|-----|-----|---------------------------------------|-------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----------------------|----------------------------|------|------------|----------|--------|------------------|--------|--------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | P | | P | | | | | | P | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | P | P | P | P | | | | | P | P | P | | 4, 5, 6, 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | P | | P | | | | | | P | P | P | | 6 |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventiona
I) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

19

PVT-375SC Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
-----------------------------------------

| Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Micro Pure | Apli Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|---------------------------------|---|---|-----|-----|---------------|----------------------|-------------------|------------|-----------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|---------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | P | | | | P | | | | | P | | | | | 6 |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | P | | P | P | P | P | | | | P | P | P | P | | 4,5,6,7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | P | | | | | | | | | P | P | P | | | 6 |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

20

PVT-382BT Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of O
---------------------------------

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color Doppler | Precision Imaging | Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D
(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|----------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----------------------|----------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | 2 | P | P | | P | | | P | | | | P | P | | P | P | | | 6 |
| Abdominal | | P | P | P | P | P | P | 2 | P | P | | P | | | P | | | | P | P | P | P | P | | | 6,7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | 2 | P | P | | P | | | P | | | | P | P | P | P | P | | | 6 |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

21

PVT-674BT Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | | | | | | | | | | | | | | Other
[Note] | | | | | | | | |
|------------------------------------------------|-------------------|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|----------|------------|-----------------|----------------------------|------|------------|----------|--------|------------------|--------|--|
| | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | |
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | | P | | N | P | | | | | P | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | P | | | | | P | | | | 7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | | P | | | P | | | | | P | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

22

PVT-675MVL Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
-----------------------------------------
Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor DopplerCombined (Specify) *Precision ImagingMicro PureApli PureBEAMPowerTDIElastographyShear waveSMI(ADF)4D3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther [Note]
Ophthalmic
FetalPPPP2PPPPPPPPP8
AbdominalPPPP2PPPPPPPPP8
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPPPPPPPP8
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD

  • Note 4 ATI
    Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

23

PVT-675MVS Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Op
----------------------------------

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Micro Pure | Apli Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
|------------------------------------------------|-------------------|---|---|-----|-----|---------------|----------------------|-------------------|------------|-----------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|--------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | P | P | P | | P | 2 | P | P | P | | P | | | P | P | P | P | P | P | | | | 8 | |
| Abdominal | | P | P | P | | P | 2 | P | P | P | | P | | | P | P | P | P | P | P | | | | 8 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | 2 | P | P | P | | P | | | P | P | P | P | P | P | | | | 8 | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

24

PVT-681MVL Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Op
----------------------------------

| Clinical Application | Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Micro Pure | Apli Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
|---------------------------------|------------------------|-------------------|---|---|-----|-----|---------------|----------------------|-------------------|------------|-----------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|--------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | | | P | P | P | P | P | 2 | P | P | P | | P | | | | | | | | | | | | 7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | P | P | P | P | P | 2 | P | P | P | | P | P | P | P | P | P | P | | | | | | 8 | |
| Trans-vaginal | | | P | P | P | P | P | 2 | P | P | P | | P | P | P | P | P | P | P | | | | | | 8 | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

25

PVT-712BT Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
Clinical ApplicationMode of Operation[Note]
Specific
(Tracks 3)BMPWDCWDColor DopplerPrecision Imaging
Combined (Specify) *Apli PureMicro PureBEAMPowerTDIElastographyShear waveSMI(ADF)4D3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther
Ophthalmic
Fetal
AbdominalPPPP2PPPPP
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPPPP
Small Organ (Note 1)
Neonatal CephalicPPPP2PPPPP
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

26

PVT-745BTF Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other
[Note] |
|------------------------------------------------|------------------------|---|-----|-----|---------------|----------------------|-------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|-----------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | P | | | P | | | | P | | | P | P | | | | | 7 |
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | | | P | | | | P | | | P | P | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | | | P | | | | P | | | P | P | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

27

PVT-745BTH Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Op
----------------------------------
Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor DopplerPrecision Imaging
Combined (Specify) *Apli PureMicro PureBEAMPowerTDIElastographySMI(ADF)Shear wave4D
(Volume color)3D ColorSTICSTIC ColorSmart 3DSmart Navigation2D WMTOther [Note]
Ophthalmic
Fetal
AbdominalPPPPP2PPPPPP7
Intra-operative (Abdominal)PPPPP2PPPPPP
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)PPPPP2PPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

28

PVT-745BTV Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Op
----------------------------------
Clinical ApplicationMode of OperationOther[Note]
Specific
(Tracks 3)BMPWDCWDColor DopplerCombined (Specify) *Precision ImagingMicro PureApli PureBEAMPowerTDIElastographyShear waveSMI(ADF)4D3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMT
Ophthalmic
Fetal
AbdominalPPPPP2PPPPPP
Intra-operative (Abdominal)PPPPP2PPPPP
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)PPPPP2PPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

29

PVT-781VT Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Combined (Specify) * | Precision Imaging | Micro Pure | Apli Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D
(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|------------------------|---|-----|-----|----------------------|-------------------|------------|-----------|------|-------|-----|--------------|----------|------------|----------------------|----------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | 2 | P | P | P | | P | | | P | | | | | | | | | 7 | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | P | P | P | P | 2 | P | P | P | | P | | P | P | P | | | | | | P | P | | 6 | |
| Trans-vaginal | P | P | P | P | 2 | P | P | P | | P | | P | P | P | | | | | | P | P | | 6 | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

30

PVT-781VTE Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
|------------------------------------------------|---|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|--------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | P | | | | | | | | | 7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | P | P | P | | P | 2 | P | P | | P | | P | P | P | | | | | | P | P | | 6 |
| Trans-vaginal | P | P | P | | P | 2 | P | P | | P | | P | P | P | | | | | | P | P | | 6 |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

31

PVL-715RST Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
|------------------------------------------------|-------------------|---|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|--------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | | P | P | P | | P | 2 | P | P | | P | | | | | | | | | | | | 7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | P | P | P | | P | 2 | P | P | | P | P | P | | | | | | | | P | P | | 6 |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

32

Transducer: PVT-770RT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of OperationOther[Note]
Specific
(Tracks 3)BMPWDCWDColor DopplerPrecision Imaging
Combined (Specify) *Apli PureMicro PureBEAMPowerTDIElastographyShear wave
SMI(ADF)4D
(Volume color)3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMT
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPP2PPPP
Trans-vaginalPPPP2PPPP
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K151451 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

33

Transducer: PLI-1205BX

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | SMI(ADF) | Elastography | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Smart Navigation | Fusion | 2D WMT | Other | [Note] |
|------------------------------------------------|---|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|----------|--------------|------------|----|----------------------------|------|------------|----------|------------------|--------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | | | | | | | | | | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | P | P | P | P | P | P | | | | | P | P | P | | | 6 |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | P | P | P | P | P | | | | | P | P | P | | | 6,8(N) |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | P | P | P | P | P | | | | | P | P | P | | | 6,8(N) |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | P | P | P | P | P | P | | | | | P | P | P | | | 6 |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

34

Transducer: PLI-2002BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D
(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|------------------------|---|-----|-----|---------------|----------------------|-------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----------------------|----------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | | | P | | | P | | | | | | P | P | | | 6 | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | | | P | | | P | | | | | | P | P | | | 6 | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | | | P | | | P | | | | | | P | P | | | 6 | |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | | | P | | | P | | | | | | P | P | | | 6 | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | | | P | | P | P | | | | | | P | P | | | 6 | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers:K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

35

Transducer: PLI-2004BX

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Micro Pure | Apli Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D
(Volume color) | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|------------------------|---|-----|-----|---------------|-------------------------------------------|------------|-----------|------|-------|-----|--------------|----------|------------|----------------------|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | | P | P | | P | P | | | | | | P | P | P | | 6 |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | | P | P | | P | P | | | | | | P | P | P | | 6,8(N) |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | | P | P | | P | P | | | | | | P | P | P | | 6,8(N) |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | | P | P | | P | P | | | | | | P | P | P | | 6 |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090

Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

36

Transducer: PLI-3003BX

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application | Mode of Operation

| Clinical Application
(Tracks 3) | Specific | Mode of Operation | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Micro Pure | Apli Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D
(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
|------------------------------------|----------|-------------------|---|---|-----|-----|---------------|-------------------------------------------|------------|-----------|------|-------|-----|--------------|----------|------------|----------------------|----------|------|------------|----------|--------|------------------|-----------|--------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | N | N | N | | N | 2 | N | N | | | N | | | N | | | | | | N | N | | | 6(N) | |
| Musculo-skeletal (Superficial) | N | N | N | | N | 2 | N | N | | | N | | | N | | | | | | N | N | | | 6(N),8(N) | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: N/A Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

37

PLT-704SBT Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of O
---------------------------------

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D
(Volume color) | 3D Color
STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | Note |
|------------------------------------------------|------------------------|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----------------------|------------------|------------|----------|--------|------------------|--------|-------|------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | | | | | | | | | | 7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | | P | P | | P | | | | | P | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | | P | P | | P | | | | | P | | | | | |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | | P | P | | P | | | | | P | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | | P | P | | P | | | | | P | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

38

PLT-705BT Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of OperationOther[Note]
Specific
(Tracks 3)BMPWDCWDColor DopplerCombined (Specify) *Precision ImagingMicro PureApli PureBEAMPowerTDIElastographyShear wave
SMI(ADF)4D
(Volume color)3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMT
Ophthalmic
Fetal
AbdominalPPPP2PPPPP7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)PPPP2PPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PPPPPP
Musculo-skeletal (Superficial)PPPP2PPPPPP
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPPPPP
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

39

PLT-705BTF Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
-----------------------------------------

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|---|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | P | | P | | | | P | | | | | | P | | | | |
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | | P | | | | P | | | | | | P | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

40

PLT-705BTH Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Op
----------------------------------

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|-------------------|---|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | 2 | P | P | | P | | | | P | | | | | P | | P | | | |
| Intra-operative (Abdominal) | | P | P | P | P | P | 2 | P | P | | P | | | | P | | | | | P | | P | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

41

PLI-705BX Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | Note |
|------------------------------------------------|-------------------|---|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | | P | P | P | | P | 2 | P | P | | P | P | | P | | | | | | P | P | | | | 6,7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | P | P | P | | P | 2 | P | P | | P | P | | P | | | | | | P | P | | | | 6 |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | P | P | P | | P | 2 | P | P | | P | P | | P | | | | | | P | P | | | | 6 |
| Musculo-skeletal (Superficial) | | P | P | P | | P | 2 | P | P | | P | P | | P | | | | | | P | P | | | | 6 |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | 2 | P | P | | P | P | | P | | | | | | P | P | | | | 6 |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

42

PLT-1005BT Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of O
---------------------------------

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Combined (Specify) *
Precision Imaging | Color Doppler | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D
(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|---|---|-----|-----|-------------------------------------------|---------------|-----------|------------|------|-------|-----|--------------|----------|------------|----------------------|----------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | | | | | | | | | | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | P | P | P | | P | P | P | | | | | P | P | P | | 6 |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | | P | P | | P | P | | | | | | P | P | P | | 6,8(N) |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | | P | P | | P | P | | | | | | P | P | P | | 6,8(N) |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | | P | P | | P | P | | | | | | P | P | P | | 6 |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

43

PLT-1202BT Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of C
---------------------------------
Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMCWDPWDColor DopplerCombined (Specify) *Precision ImagingApli PureMicro PureBEAMPowerTDIElastographyShear waveSMI(ADF)4D
(Volume color)3D ColorSTICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther [Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)PPPPP2PPPPPP6
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)PPPPP2PPPPPP6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPPP2PPPPPP6
Musculo-skeletal (Superficial)PPPPP2PPPPPP6
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPPP2PPPPPPPP
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

44

PLT-1204BT Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Micro Pure | Apli Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|------------------------|---|-----|-----|---------------|-------------------------------------------|------------|-----------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | P | | | | | | P | | | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | | P | P | | P | P | | | | | | P | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | | P | P | | P | P | | | | | | P | | | | 8(N) |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | | P | P | | P | P | | | | | | P | | | | 8(N) |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | | P | P | | P | P | | | | | | P | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

45

PET-508MA Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Micro Pure | Apli Pure | BEAM | Power | Elastography | TDI | Shear wave | SMI(ADF) | 4D
(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|---|---|-----|-----|---------------|-------------------------------------------|------------|-----------|------|-------|--------------|-----|------------|----------|----------------------|----------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | | | | | | P | | | | | | | | | | | P | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

46

Transducer: PET-512MC

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
-----------------------------------------
Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor DopplerPrecision ImagingCombined (Specify) *Micro PureApli PureBEAMPowerElastographyTDIShear waveSMI(ADF)4D3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)PPPPP3PPP
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

47

Transducer: PET-512MD

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
-------------------------------------------
Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor DopplerPrecision Imaging
Combined (Specify) *Apli PureMicro PureBEAMPowerElastographyTDIShear waveSMI(ADF)4D3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)PPPPP3PPP
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

48

Transducer: PEI-512VX

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the
Clinical ApplicationMode of Operation
SpecificLNPCQAMB

| Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Micro Pure | BEAM | Power | Elastography | TDI | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|---------------------------------|---|---|-----|-----|---------------|----------------------|-------------------|------------|------|-------|--------------|-----|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|-----------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | | | | | P | | | | P | P | | | | | | P | 8,9,10,11 |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

49

PET-805LA Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Micro Pure | Apli Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|---|---|-----|-----|---------------|-------------------------------------------|------------|-----------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | | | | | | | | | | 7 | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | P | P | P | | P | 2 | P | P | | P | | P | P | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

50

PC-20M Transducer:_

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of OperationOther[Note]
Specific
(Tracks 3)BMPWDCWDColor DopplerCombined (Specify) *Precision ImagingMicro PureApli PureBEAMPowerTDIShear waveSMI(ADF)4D
(Volume color)3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMT
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricP
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultP
Cardiac PediatricP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselP
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

51

Toshiba America Medical Systems, Inc.

510(k) Premarket Notification Aplio i900, i800, i700 V3.1 Diagnostic Ultrasound System

System: Aplio i900, i800, i700, i600 V3.1 Transducer: PC-50M

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor DopplerPrecision Imaging
Combined (Specify) *Micro Pure
Apli PureBEAMPowerElastography
TDIShear wave
SMI(ADF)4D
(Volume color)
3D ColorSTICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricP
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultP
Cardiac PediatricP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselP
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K173090 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Note 7 CHI (Per FDA approved contrast agent prescribing information)

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

52

510(k) SUMMARY

K182679

  • SUBMITTER'S NAME: 1. Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550
    1. OFFICIAL CORRESPONDENT Naofumi Watanabe
    1. ESTABLISHMENT REGISTRATION: 9614698

CONTACT PERSON: 4.

Orlando Tadeo, Jr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459

  1. Date Prepared: September 14, 2018

TRADE NAME(S): 6.

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 Aplio i900 Model TUS-Al900 Software Version V3.1 Aplio i800 Model TUS-AI800 Software Version V3.1 Aplio i700 Model TUS-AI700 Software Version V3.1 Aplio i600 Model TUS-AI600 Software Version V3.1

7. COMMON NAME:

System, Diagnostic Ultrasound

8. DEVICE CLASSIFICATION:

Class II

Ultrasonic Pulsed Doppler Imaging System – Product Code: 90-IYN [per 21 CFR 892.1550] Ultrasonic Pulsed Echo Imaging System – Product Code: 90-IYO [per 21 CFR 892.1560] Diagnostic Ultrasonic Transducer – Product Code: 90-ITX [per 21 CFR 892.1570]

PHONE: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780

53

9. PREDICATE DEVICE:

ProductMarketed by510(k) NumberClearance Date
Aplio i900/i800/i700/i600
Diagnostic Ultrasound System,
V2.4
(Primary Predicate Device)Canon Medical
Systems USAK173090January 11, 2018
Philips EPIQ 5 Diagnostic
Ultrasound System
(Reference Predicate Device)Philips HealthcareK172607October 4, 2017
Voluson E10
(Reference Predicate Device)GE HealthcareK172342September 29, 2017

10. REASON FOR SUBMISSION:

Modification of a cleared device

11. DEVICE DESCRIPTION:

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600, V3.1 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 30 MHz.

12. INDICATIONS FOR USE:

The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-Al700 and Aplio i600 Model TUS-Al600 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Aplio i900/i800/i700/i600, Diagnostic Ultrasound System, V2.4, K173090, marketed by Canon Medical Systems USA. The Aplio i900 Model TUS-A1900, Aplio i800 Model TUS-Al800, Aplio i700 Model TUS-A1700 and Aplio i600 Model TUS-Al600, V3.1 function in a manner similar to and is intended for the same use as the predicate devices. The subject device includes modifications to the cleared device which improves upon existing features. Also, this submission includes details regarding new features determined to be substantially equivalent to features cleared under the predicate devices referenced within this submission.

| Device | Aplio i900/i800/
i700/i600
V3.1 | EPIQ5 | Voluson
E10 | Comment |
|----------------------------|---------------------------------------|---------|----------------|---------|
| 510(k) Clearance
Number | Subject Device | K172607 | K172342 | |
| | Limb Volume
Measurement | Yes | | Yes |

New features and Improvements to previously cleared functions:

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| Dual Volume

DisplayYesYesImprovement
DeviceAplio i900/i800/i700/i600 (V3.1)Aplio i900/i800/i700 /i600 (V2.4)Comment
510(k) Clearance
NumberSubject DeviceK173090
OB Body MarkYesYes-Breast Scan Guide Feature
New Feature
Contrast ImagingYesYes-Contrast Vector Imaging
Feature
New Feature
YesYes-Quad Contrast Feature
Improvement(s)
3D Wall Motion
TrackingYesYes-TEE Transducer Feature
Improvement(s)
2D Wall Motion
TrackingYesYes-Fetal Heart Feature
-DSI Feature Improvement(s)
Smart FusionYesYes-PWD/CWD Feature
Improvement(s)
PST-28BTYesNoNew transducer
PVT-574BTYesNoNew transducer
PVI-574BXYesNoNew transducer
PVT-770RTYesNoNew transducer
PLI-3003BXYesNoNew transducer

14. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC60601-1-2 Edition 3: 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, IEC 60601-2-37 Edition 2.0 2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, ANSI AAMI IEC 62304:2006 Medical device software - Software life cycle processes, NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 and ISO 10993-1 Fourth edition 2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)],ISO10993-5 Third edition 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity,

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ISO10993-10 Third Edition 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

15. TESTING

Risk Analysis, Verification/Validation testing conducted through bench testing and clinical evaluation which are included in this submission demonstrates that the requirements for the new and improved features have been met.

Performance Testing - Assessment of Limb Volume Measurement

The primary objective of this study confirmed that Limb Volume Measurement is substantially equivalent to the predicate device with regard to the following:

(I) New growth predictor of Fractional limb volume (Fractional arm volume (AVol), Fractional thigh volume (TVol)) are correctly calculated using the test data phantom and in a clinical evaluation (II) Estimated fetal weight (EFW) is correctly calculated using either the new growth predictor above or in combination with the existing growth predictor (such as abdominal circumference (AC), head circumference (HC), biparietal diameter (BPD), and femur length (FL) using the clinical data)

Performance Testing - Assessment of Contrast Vector Imaging

The primary objective of this study confirmed that this feature is substantially equivalent to the predicate device with regard to the following:

(I) the color mapping image is depicted correctly in terms of the spatial distribution of the moving bubble including Arrival time, Direction, Velocity, Direction-Center, etc. using a wire phantom and test data

(II) quantitative measurement results (Velocity and Direction) are obtained correctly using a string phantom, a flow phantom and test data

Performance Testing - Assessment of Breast Scan Guide

The primary objective of this study confirmed that this feature is substantially equivalent to the predicate device with regard to the following:

(I) the subject device correctly displays the locational information of an object of interest in the Xray image received from a mammography system. More specifically, the location information of the breast body mark in the ultrasound system matches with the lines calculated using the locational data directly obtained from X-ray image

Additional performance testing, using phantom and volunteer studies, was conducted to assess improvements to existing features including 3D Wall Motion Tracking, 2D Wall Motion Tracking, Smart Fusion and 2nd Console. Results of all these studies demonstrated that the improvements met specifications and performed as intended.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Additionally, testing of this device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices.

16. CONCLUSION

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-Al600, V3.1 is substantially equivalent to the predicate devices. The subject devices function in a manner similar to and is intended for the same use as the predicate devices,

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as described in the labeling. Based upon the bench testing, clinical evaluation, acquisition of representative clinical images, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use.