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K Number
K191467
Device Name
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
Manufacturer
Canon Medical Systems Corporation
Date Cleared
2019-07-19

(46 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-Al900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 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.
Device Description
The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600, V4.0 are mobile, compact diagnostic ultrasound systems which implement the latest technologies. 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

K182679, K181098, K180572

Not Found

No
The document does not explicitly mention the use of AI, ML, or related terms like deep learning or neural networks in the device description or performance studies. While image processing improvements are mentioned, this does not automatically indicate AI/ML.

No.
The device is indicated for visualization and diagnosis, not for treating any condition.

Yes

The "Intended Use / Indications for Use" section explicitly states that the systems "provide image information for diagnosis." Additionally, the "Device Description" clearly identifies them as "mobile, compact diagnostic ultrasound systems."

No

The device description explicitly states it is a "mobile, compact diagnostic ultrasound system" and mentions "a wide array of probes," indicating it includes hardware components beyond just software.

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

Here's why:

  • Intended Use: The intended use clearly states the device is for "visualization of structures, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis". This describes an in-vivo imaging device, not a device that analyzes samples taken from the body (which is the core function of an IVD).
  • Device Description: The description details a "diagnostic ultrasound system" that uses ultrasound waves to create images. This is consistent with an in-vivo imaging modality.
  • Input Imaging Modality: The input is "Ultrasound," which is an in-vivo imaging technique.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with IVD devices.

In summary, the device is a diagnostic ultrasound system used for imaging the inside of the human body, which falls under the category of medical imaging devices, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

The Diagnostic Ultrasound Systems Aplio i900 Model TUS-Al900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 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.

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, V4.0 are mobile, compact diagnostic ultrasound systems which implement the latest technologies. 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

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast, testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (conventional and superficial), laparoscopic

Indicated Patient Age Range

pediatric, neonatal, adult

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

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.

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

  • Performance Testing – Assessment of New Feature, Aortic Valve Analysis (AV Analysis)
    • Bench Assessment of AV Analysis: This study confirmed that AV Analysis provides measurement values of the aortic valve complex that are substantially equivalent to those by the predicate function.
    • Clinical Evaluation of AV Analysis: This study confirmed that this function provides a faster and easier workflow in comparison to the predicate function.
  • Performance Testing - Assessment of New Feature, BI-RADS Checklist
    • This study confirmed the following: I) that this function provides a check list with options standardized according to ACR BI-RADS and that (II) this function establishes a worksheet displaying check items in the specified layout.
  • Performance Testing - Assessment of New Feature, TI-RADS Checklist
    • This study confirmed the following: I) that this subject function provides a check list with options standardized according to ACR TI-RADS and automatically provides clinical assessments (risk classification in terms of Thyroid cancer) standardized according to ACR TI-RADS and that (II) this function establishes a worksheet displaying check items in the specified layout.
  • Performance Testing - Assessment of Improved Feature, 2D Wall Motion Tracking for Fetal Heart one cycle detection
    • Bench Assessment of 2D Wall Motion Tracking for Fetal Heart one cycle detection: This study confirmed the following: that I) the measurement values by the subject function are substantially equivalent to the predicate function and (II) that the operation time is reduced as compared to the predicate function.
    • Clinical Evaluation of 2D Wall Motion Tracking for Fetal Heart one cycle detection: This study confirmed the following: I) that the subject function automatically provides a clinically appropriate candidate one heart cycle period and (II) that workflow is improved by comparison of the subject function to the predicate.
  • Additional performance testing, using test data and volunteer studies, was conducted to assess improvements to existing features including Color Doppler image processing, 4D measurements, Mitral Valve Analysis, and E/A measurements. Results of all these studies demonstrated that the improvements met specifications are performed as intended.

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

Not Found

Predicate Device(s)

K182679, K181098, K180572

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 19, 2019

Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K191467

Trade/Device Name: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: Mav 31, 2019 Received: June 3, 2019

Dear Mr. Tadeo:

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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K191467

Device Name

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0

Indications for Use (Describe)

The Diagnostic Ultrasound Systems Aplio i900 Model TUS-Al900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 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.

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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Transducer:

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

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDCombined (Specify)Precision ImagingMicro PureApli PureBEAMPowerTDIShear wave
SMI(ADF)4D
(Volume color)3D Color
(Volume color)STICSTIC ColorSmart 3DSmart NavigationFusion2D WMTOther [Note]
Ophthalmic
FetalPPPP2PPPPPPPPPPPP6,8
AbdominalPPPPP2,3PPPPPPPPPPPP4,5,6,7,8
Intra-operative (Abdominal)PPPP2PPPP
Intra-operative (Neuro)
LaparoscopicPPPP2PPPPP
PediatricPPPPP2,3PPPPPPPPPPPP6,8
Small Organ (Note 1)PPPP2PPPPPPPPPPP6
Neonatal CephalicPPPPP3PP
Adult CephalicPPPPP3PPPPP6,
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 AdultPPPPP3PPPPPP7,8,9,10
Cardiac PediatricPPPPP3PPPPP7,8,9,10
Intravascular (Cardiac)
Trans-esoph. (Cardiac)PPPPP3PPPP8,10,11
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: K182679 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

System: Aplio i900, i800, i700,i600 V4.0 Transducer: PST-28BT*

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 ColorSmart 3DFusionSmart Navigation2D WMTOther [Note]
Ophthalmic
Fetal
AbdominalPPPPP3PPPPP6(P),7(P),8(P)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal CephalicPPPPP3PP
Adult CephalicPPPPP3PPPP6(P)
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultPPPPP3PPPPP7(P),8(P)
Cardiac PediatricPPPPP3PPPP7(P),8(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: K182679 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

Note 11 Mitral Valve Analysis

*This transducer Model Name was incorrectly listed as "PSI-28BT" in predicate submission K182679. The correct reference was provided to FDA in "Add to file K182679".

5

Transducer:

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

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor DopplerCombined (Specify) *Precision ImagingApli PureMicro PureBEAMPowerTDIElastographyShear waveSMI(ADF)4D3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther[Note]
Ophthalmic
Fetal
AbdominalPPPPP3PPPPP6(P)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP3PPPPP6(P)
Small Organ (Note 1)
Neonatal CephalicPPPPP3PP
Adult CephalicPPPPP3PPPP6(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: K182679 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 | 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 | 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: K182679 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: PST-25BT

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

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDPrecision ImagingCombined (Specify) *Micro PureApli PureBEAMPowerTDIElastographyShear waveSMI(ADF)4D
(Volume color)3D ColorSTICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther[Note]
Ophthalmic
Fetal
AbdominalPPPPP3PP
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP3PPP
Small Organ (Note 1)
Neonatal CephalicPPPPP3PPP
Adult CephalicPPPPP3PPP
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: K182679 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

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PST-30BT 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 | 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 | | | | | | | | | 7 | |
| 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 | | | 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 | 7 | |
| Cardiac Pediatric | P | P | P | P | P | 3 | | | | 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: K182679 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:

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

| Specific
(Tracks 3) | 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 | | | | | | | | | | | | | | | | | | | | | | | | |
| 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: K182679 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

Transducer:PST-65BT

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 | Shear wave
Elastography | 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 | N | N | N | N | N | 3 | N | | | N | | 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 | N | N | N | N | N | 3 | N | | | N | N | | | | | | | | N | | |
| Cardiac Pediatric | N | N | N | N | N | 3 | N | | | N | N | | | | | | | | 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)

Note8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

11

PSI-30VX Transducer:

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

Clinical ApplicationMode of
-------------------------------
Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor DopplerCombined (Specify) *
Precision ImagingApli PureMicro PureBEAMPowerTDIElastographyShear wave
SMI(ADF)4D
(Volume color)
3D ColorSTICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther[Note]
Ophthalmic
Fetal
AbdominalPPPPP3 PPPPPPPP7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP3 PPPPPPPP
Small Organ (Note 1)
Neonatal Cephalic
Adult CephalicPPPPP3 PPPPPP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac AdultPPPPP3 PPPPPPPP7,8,9,10
Cardiac PediatricPPPPP3 PPPPPPPP7,8,9,10
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:K182679 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-40VX Transducer:

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

Clinical ApplicationMode of
-------------------------------
Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor DopplerCombined (Specify) *Precision ImagingApli PureMicro PureBEAMPowerTDIElastographySMI(ADF)Shear wave4D3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther [Note]
Ophthalmic
FetalPPPPP2PPPP
AbdominalPPPPP3PPPPPP7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP3PPPPPP
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 AdultPPPPP3PPPPPP7,8,9,10
Cardiac PediatricPPPPP3PPPPPP7,8,9,10
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: K182679 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

PSI-50VX Transducer:

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

Mode of Operation Clinical Application

ாறியின் 1 ர்நாவில்ப191000 01 0 00000000
Specific
(Tracks 3)BMamaamplayed begipəds) pəuiquloສິນເກີຣ໌ເພາະ ແດນຣາເວອາand liquiceo PurceMAGAwww.IQTបុបមរភិបាល ប្រជាជាតិACA)IMShear waveCa supportunionOLLSSTIC ColorDE 118muoisn Foilsgiven 118mLINM azOther
[Note]
Ophthalmic
FetalPPPP2PPPb
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP3bPPPbP
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 AdultPbbbP3bPbbbb7,8,9,10
Cardiac PediatricPbbPP3PbbPPb7,8,9,10
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: K182679 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

14

Transducer: PVI-475BT

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

mended OSE. Diagnostic untrasound imaging of Truid now andrySis
Clinical ApplicationMode 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 | P | P | P | | P | 2 | P | P | | | P | P | | P | | | | | P | | | P | | |
| Abdominal | 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 | 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: K182679 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: PVI-475BX

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

Clinical Application Mode of Operation

.
Specific
(Tracks 3)BMamaamaldo (10)oırəədç) pəuiqunoรับเชิริย์น์ แบรรเวอสil Pulleice PurceMAGEPowerIQIបុបមរភិបាលប្រជាជាACLA)IMSEEM WareCa supportunities andSITSSTCCCCccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccDE PremiuoisnDITERIARN 11811LINM azOther
[Note]
Ophthalmic
FetalPbbP2PPPPPPP
AbdominalPPPP2PPPPPPPPP4,5,6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPbbP2PbPPPPb6
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: K182679 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: PVI-482BX

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMamaന്നും വക്ഷേത്രം അവലംബം പ്രശസ്തമായി വിവ്യത്തിന്റെ വിശ്വാസം വേണ്ടുന്നു. അവലംബം അവലംബം പ്രശസ്ത്രവും വയസ്തുന്നും അവലംബം പ്രശസ്ത്രത്തിനും അവലംബം അവലംബം അവലംബം അവലംബംologic proposition(yıɔədç) pəuiqurรินทุกิชานี แบบริเวอərə qalında çəkildən bir və qalınmışdır. Bu mərkəzi və qalınmışdır. Bu mərkəzi və qalınmışdır. Bu mərkəzi və qalınmışdır. Bu mərkəzi və qalınmışdır. Bu mərkəzi və qalınmışdıMicro PurceMA.MIPowerIQIប្រជាជនជាតិACLA)IMShew wavea suppo suppo deSITSTTCCCCGGTCSurfamisuoisnits given 118mLINK OZOther
[Note]
Ophthalmic
FetalNNNN2NNNNN6
AbdominalNNNN2NNNNNNN6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNN2NNNNNNN6
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-574BT

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 | SMI(ADF) | Elastography | Shear wave | 4D
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
|------------------------------------------------|------------------------|---|-----|-----|---------------|----------------------|-------------------|-----------|------------|------|-------|-----|----------|--------------|------------|----------------------|------|------------|----------|--------|------------------|--------|----------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P | | P | P | | | P | | | | | P | | | P | 6(P), 8(P) |
| Abdominal | P | P | P | | P | P | P | P | | P | P | | P | P | P | | | | P | P | P | P | 6(P),7(P),8(P) |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | | P | P | | | P | | | | | P | P | P | | 6(P),8(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: K182679 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

Transducer: PVI-574BX

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 | Precision Imaging
Combined (Specify) * | Micro Pure | Apli 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 | | P | P | P | P | P | 2 | P | P | | P | P | | P | | | | P | | P | P | | 6(P), 8(P) | |
| Abdominal | | P | P | P | P | P | 2 | P | P | | P | | | P | P | | | P | P | P | P | | 6(P),7(P),8(P) | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | 2 | P | P | | P | | | P | | | | P | P | P | | | 6(P),8(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: K182679 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

uoisn the the mig INM (1) Other

[Note]

SILS

TIC CC

e pristi

System: Aplio i900, i800, i700, i600 V4.0

Transducer: PVT-482BT

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

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor DopplerCombined (Specify) *Precision ImagingApli PureMicro PureBEAMPowerTDIElastographySMI(ADF)Shear wave4D3D Color
(Volume color)
Ophthalmic
FetalPPPP2PPPPP6
AbdominalPPPP2PPPPPPP6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPPPPPP6
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: K182679 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-375BT 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 | 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 | | | | | |
| Abdominal | P | P | P | | P | 2 | 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 | 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: K182679 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-375SC Transducer:

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

Clinical Application Mode of Operation

1 1000 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Specific
(Tracks 3)BMamaന്നും വഹാClor Dople(Ajisədç) pəuiquvoguigeml uoisiperand liquMicro PureMA.MAowerIdlקלא מערכת המועד לינוע לא מערכת המועד ליינו לא מעולם למשלה במשלב את המועד המועד למשלה במשלב המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועFICA)IMSAEM MEVEਹalolos aminon) afOLLSTIC ColoDE 118muoisnDIEBIAEN 118mLINM azOther
[Note]
Ophthalmic
FetalPPPP2PPPbP6
AbdominalPPPP2PPPPPbPPP4,5,6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPPbPPPર્ભ
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: K182679 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-382BT 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 OperationOther [Note]
BMPWDCWDColor DopplerPrecision Imaging
Combined (Specify) *Apli PureMicro PureBEAMPowerTDIElastographySMI(ADF)Shear wave4D
(Volume color)3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMT
Ophthalmic
FetalPPPP2PPPPPPP6
AbdominalPPPP2PPPPPPPP6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPPPPPPP6
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: K182679 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

23

PVT-674BT Transducer:

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

| 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 | | P | | | P | | P | | P | | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | P | | P | | P | | | P | | | | | 7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | 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 | | | | | | | | | | | | | | | | | | | | | | | | |
| 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: K182679 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

24

PVT-675MVL 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 PureBEAMPowerTDIElastographyShear wave
SMI(ADF)4D
(Volume color)3D ColorSTICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther[Note]
Ophthalmic
FetalPPPP2PPPPPPPPP8
AbdominalPPPP2PPPPPPPP8
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPPPPPPP8
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: K182679 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

Transducer: PVT-675MVS

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 | 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 | | P | | P | P | P | P | P | | | P | 8 |
| Abdominal | P | P | P | P | P | 2 | P | P | P | P | P | P | | P | | P | P | P | P | P | | | | 8 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | 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: K182679 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

Transducer: PVT-681MVL

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 | 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 | | | | | | | | | | | | | | 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 | | | | | | | 8 | |
| Trans-vaginal | P | P | P | | P | 2 | 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: K182679 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-712BT 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 | Smart Navigation | 2D WMT | Other | [Note] |
|---------------------------------|---|---|-----|-----|---------------|----------------------|-------------------|------------|-----------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | P | | | P | | | | | | P | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | P | | | P | | | | | | P | | | | |
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | | P | | | P | | | | | | P | | | | |
| Neonatal Cephalic | P | P | P | P | P | 2 | P | P | P | | P | | | P | | | | | | P | | | | |
| 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: K182679 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-745BTF 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 OperationOther [Note]
BMPWDCWDColor DopplerCombined (Specify) *Precision ImagingMicro PureApli PureBEAMPowerTDIElastographyShear wave
SMI(ADF)4D3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMT
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: K182679 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-745BTH 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 | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | P | | P | | | | | P | | | 7 | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | | P | | | P | | P | | | | | P | | | | |
| 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) | | | | | | | | | | | | | | | | | | | | | | | | |
| 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: K182679 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-745BTV 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 | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | P | | P | | | | P | | | | | | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | | P | | | | | | | | | P | | | P | | | |
| 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) | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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: K182679 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

PVT-781VT 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 | 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 | 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: K182679 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:

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 | 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 | | | | | P | P | | 6 | |
| Trans-vaginal | P | P | P | P | 2 | P | 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: K182679 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

PVL-715RST Transducer:

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

Clinical ApplicationMode of C
---------------------------------

| Clinical Application
Specific

(Tracks 3)Mode of Operation
BMPWDCWDColor DopplerCombined (Specify) *Precision ImagingMicro PureBEAMPowerTDIElastographyShear waveSMI(ADF)4D
(Volume color)3D ColorSTICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther[Note]
Ophthalmic
Fetal
AbdominalPPPPP2PPP7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPP2PPPPPPPP6
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: K182679 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: PVT-770RT

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 PureBEAMPowerTDIElastographyShear 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-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: K182679 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-1205BX

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)4D
(Volume color)3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther
Ophthalmic
Fetal
AbdominalPPPP2PPP7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)PPPP2PPPPPPPPPPP6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PPPPPPPPPP6,8
Musculo-skeletal (Superficial)PPPP2PPPPPPPPPP6,8
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPPPPPPPPP6
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 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-2002BT

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 ImagingApli PureMicro PureBEAMPowerTDIElastographyShear waveSMI(ADF)4D
(Volume color)3D ColorSTICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther
[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)PPPPP2PPPPPPP6
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)PPPPP2PPPPPPP6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPPP2PPPPPPP6
Musculo-skeletal (Superficial)PPPPP2PPPPPPP6
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPPP2PPPPPPPP6
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers:K182679

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

Transducer: PLI-2004BX

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

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 | SMI(ADF) | Shear wave | 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) | 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 | |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | | P | P | | P | P | | | | | P | P | P | | 6,8 | |
| 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: K182679 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

Transducer: PLI-3003BX

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

Clinical Application

| Clinical Application
(Tracks 3) | Specific | 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 | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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) | P | P | P | | P | 2 | P | P | | | P | | | P | | | | | | P | P | | | 6(P) | |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | | | P | | | P | | | | | | P | P | | | 6(P),8(P) | |
| 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: K182679 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-704SBT 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 | 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) | 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: K182679 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-705BT 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 | 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 | | | | | | |
| 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: K182679 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

PLT-705BTF Transducer:

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

Clinical ApplicationMode of Operation
-----------------------------------------
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
AbdominalPPPPP2PPPPPPP
Intra-operative (Abdominal)PPPPP2PPPPPPP
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: K182679 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-705BTH Transducer:

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

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor DopplerCombined (Specify) *Precision ImagingApli PureMicro PureBEAMPowerTDIElastographySMI(ADF)Shear wave4D3D Color
(Volume color)STICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther[Note]
Ophthalmic
Fetal
AbdominalPPPPP2PPPPPP
Intra-operative (Abdominal)PPPPP2PPPPPP
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: K182679 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

PLI-705BX Transducer:

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

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

| Clinical Application
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
(Volume color) | 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: K182679 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-1005BT 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 | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | P | | | | | | | | | | | | | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | 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 | P | 2 | P | P | P | P | P | P | P | P | P | P | P | | | P | P | P | | | 6,8 |
| Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | P | P | P | P | P | P | P | P | | | P | P | P | | | 6,8 |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | 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: K182679 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

Transducer:

ntended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDPrecision ImagingCombined (Specify) *Micro PureApli PureBEAMPowerElastographySMI(ADF)Shear wave4D3D Color
(Volume color)STICSTIC 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 vesselPPPPP2PPPPPPP

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 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: PLT-1204BT

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

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDPrecision Imaging
Combined (Specify) *Micro PureApli PureBEAMPowerTDIElastographyShear wave
SMI(ADF)4D
(Volume color)3D Color
STICSTIC ColorSmart 3DFusionSmart Navigation2D WMTOther[Note]
Ophthalmic
Fetal
AbdominalPPPP2PPPPPP7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)PPPP2PPPPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPP2PPPPPPPP8
Musculo-skeletal (Superficial)PPPP2PPPPPPPP8
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPPPPPPP
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 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

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) | Mode of Operation
B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | Elastography | TDI | 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 | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | | |
| 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: K182679 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: PET-512MC

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 | 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: K182679 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

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 DopplerCombined (Specify) *Precision ImagingMicro 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: K182679 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

Transducer: PEI-512VX

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical ApplicationMode of Operation
Specific (Tracks 3)BMPWDCWDColor DopplerCombined (Specify) *Precision ImagingMicro PureApli PureBEAMPowerTDIElastographySMI(ADF)Shear wave4D3D 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)PPPPP3PPPP8,9,10,11
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: K182679 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

PET-805LA 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 | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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: K182679 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

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 DopplerPrecision Imaging
Combined (Specify) *Apli PureMicro PureBEAMElastographyPowerTDIShear waveSMI(ADF)4D
(Volume color)3D ColorSTICSTIC 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: K182679 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

53

Toshiba America Medical Systems, Inc.

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

System: Aplio i900, i800, i700, i600 V4.0 Transducer: PC-50M

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

| 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 | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | 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 | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | P | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | P | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K182679 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

54

SYSTEMS USA, INC.

510(k) SUMMARY

    1. SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550
    1. OFFICIAL CORRESPONDENT Naofumi Watanabe
  • ESTABLISHMENT REGISTRATION: 3. 9614698

4. CONTACT PERSON:

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

    1. Date Prepared: May 31, 2019

6. TRADE NAME(S):

Diagnostic Ultrasound System Aplio i900 Model TUS-AI900 Software Version V4.0 Aplio i800 Model TUS-AI800 Software Version V4.0 Aplio i700 Model TUS-AI700 Software Version V4.0 Aplio i600 Model TUS-AI600 Software Version V4.0

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]

55

9. PREDICATE DEVICE:

ProductMarketed by510(k) NumberClearance Date
Aplio i900/i800/i700 Diagnostic
Ultrasound System, V3.1
(Primary Predicate Device)Canon Medical
Systems USAK182679October 31, 2018
ACUSON SC2000 Diagnostic
Ultrasound SystemSiemens Medical
Solutions USA, IncK181098May 31, 2018
AIXPLORER® MACH Ultrasound
Diagnostic SystemsSupersonic
ImagineK180572May 29, 2018

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, V4.0 are mobile, compact diagnostic ultrasound systems which implement the latest technologies. 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-AI700 and Aplio i600 Model TUS-AI600 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, V3.1, K182679, marketed by Canon Medical Systems USA. The Aplio i900 Model TUS-Al900, Aplio i800 Model TUS-Al800, Aplio i700 Model TUS-A1700 and Aplio i600 Model TUS-A1600, V4.0 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. This submission also includes details regarding new features determined to be substantially equivalent to features cleared under the predicate devices referenced within this submission.

56

New features and Improvements to previously cleared functions:

| Device | Aplio
i900/i800/
i700/i600
V4.0 | ACUSON
SC2000
Diagnostic
Ultrasound
System | AIXPLORER®
MACH
Ultrasound
Diagnostic
Systems | Comment |
|-------------------------------------------|------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------|-------------|
| 510(k) Clearance
Number | Subject
Device | K181098 | K180572 | |
| Aortic Valve
Analysis
(AV Analysis) | Yes (i900) | Yes | | New Feature |
| BI-RADS Checklist | Yes | | Yes | New Feature |
| TI-RADS Checklist | Yes | | Yes | New Feature |

| | Aplio i900/i800/i700
V4.0 | Aplio i600
V4.0 | Comment |
|-----------|------------------------------|--------------------|----------------|
| PST-65BT | Yes | Yes | New transducer |
| PVI-482BX | Yes | No | New transducer |

| Device | Aplio i900/i800/i700
/i600
(V3.1) | Aplio i900/i800/i700
(V4.0) | Aplio i600
(v4.0) | Comment |
|-------------------------------------------------------|-----------------------------------------|--------------------------------|----------------------|--------------------------------------------------------------------------------|
| 510(k) Clearance
Number | K182679 | Subject Device | Subject Device | |
| Doppler
Luminance | No | Yes | Yes | Improved visibility of
blood flow, Color
Doppler imaging
-Improvement |
| Volume
rendering view
(Mecha4D) | No | Yes | Yes | Previously only
available in MPR
view
-Improvement |
| 2D WMT Fetal
Heart-Fetal
One cycle
detection | No | Yes | Yes | Automated
candidate heart cycle
detection
-Improvement |
| MVA (Mitral
Valve Analysis)
-A2/P2 length | No | Yes | No | Addition of
parameters
-Improvement |
| Auto E/A | No | Yes | Yes | Automation of
previously manual
measurements
-Improvement |

57

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 ES60601-1:2012, IEC 60601-1-2 (2014), IEC 60601-2-37 (2015), IEC 62304 (2015), AIUM RTD2-2004 Output Display and ISO 10993-1(2009) standards.

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.

15.1 Performance Testing – Assessment of New Feature, Aortic Valve Analysis (AV Analysis) Bench Assessment of AV Analysis

This study confirmed that AV Analysis provides measurement values of the aortic valve complex that are substantially equivalent to those by the predicate function.

Clinical Evaluation of AV Analysis

This study confirmed that this function provides a faster and easier workflow in comparison to the predicate function.

15.2 Performance Testing - Assessment of New Feature, BI-RADS Checklist

This study confirmed the following: I) that this function provides a check list with options standardized according to ACR BI-RADS and that (II) this function establishes a worksheet displaying check items in the specified layout.

15.3 Performance Testing - Assessment of New Feature, TI-RADS Checklist

This study confirmed the following: I) that this subject function provides a check list with options standardized according to ACR TI-RADS and automatically provides clinical assessments (risk classification in terms of Thyroid cancer) standardized according to ACR TI-RADS and that (II) this function establishes a worksheet displaying check items in the specified layout.

15.4 Performance Testing - Assessment of Improved Feature, 2D Wall Motion Tracking for Fetal Heart one cycle detection

Bench Assessment of 2D Wall Motion Tracking for Fetal Heart one cycle detection

This study confirmed the following: that I) the measurement values by the subject function are substantially equivalent to the predicate function and (II) that the operation time is reduced as compared to the predicate function.

Clinical Evaluation of 2D Wall Motion Tracking for Fetal Heart one cycle detection

This study confirmed the following: I) that the subject function automatically provides a clinically appropriate candidate one heart cycle period and (II) that workflow is improved by comparison of the subject function to the predicate.

58

Additional performance testing, using test data and volunteer studies, was conducted to assess improvements to existing features including Color Doppler image processing, 4D measurements, Mitral Valve Analysis, and E/A measurements. Results of all these studies demonstrated that the improvements met specifications are 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, V4.0 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, as described in the labeling. Based upon the bench testing, clinical evaluation, successful completion of software validation of risk management and design controls, it is concluded that this device is safe and effective for its intended use.