Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4

• K Number: K173090
• Device Name: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4
• Manufacturer: Toshiba Medical Systems Corporation
• Date Cleared: 2018-01-11 ( 104 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The Diaqnostic 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 usinq ultrasound and to provide image information for diaqnosis in the followinq 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-A1600, V2.4 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 20 MHz.

Predicate Devices

K163702, K030455, K131514, K120221, K140729, K162269, K062247

Reference Devices

K131514, K120221

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
While the device names include "AI" (Aplio i900 Model TUS-AI900, etc.), the summary does not explicitly mention the use of AI, ML, or related terms like DNN. The performance testing descriptions focus on specific features (3D WMT, Auto-EF, Z-Score, MPI, MVA, 4D Imaging) and their performance metrics, but do not describe the underlying technology as AI/ML. The lack of information on training/test sets and annotation protocols further contributes to the uncertainty. The "AI" in the model name could refer to something other than artificial intelligence in this context.

Therapeutic

No
The device's Intended Use / Indications for Use clearly states its purpose is for "visualization of structures, and dynamic processes... using ultrasound and to provide image information for diagnosis," indicating it is a diagnostic tool, not a therapeutic one.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states: "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 usinq ultrasound and to provide image information for diaqnosis." Also, the "Device Description" explicitly calls them "mobile diagnostic ultrasound systems."

SaMD (Software as a Medical Device)

No

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

IVD (In Vitro Diagnostic)

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

Here's why:

• IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this system is used for the visualization of structures and dynamic processes within the human body using ultrasound. It directly interacts with the patient's body to generate images.
• IVDs typically involve analyzing biological samples. There is no mention of collecting or analyzing blood, urine, tissue, or any other biological specimen.
• The device description and performance studies focus on imaging and measurement within the body. The studies involve phantoms and volunteers/patients being scanned directly with ultrasound, not the analysis of samples in a lab setting.

Therefore, this device is a diagnostic imaging system, specifically an ultrasound system, and does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are 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-A1600, V2.4 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 20 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) and laparoscopic.

Indicated Patient Age Range

Adult and Pediatric (including neonatal and fetal).

Intended User / Care Setting

Not Found

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

Not Found

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

Performance Testing – Assessment of 3D WMT:
Left Ventricle Analysis: The subject device demonstrated equivalency in terms of volume measurement feature (EDV/ESV/EF) and strain measurement feature (Area Change Ratio, Global Longitudinal Strain, Global Circumference Strain, Global Radial Strain).
Left Atrium Analysis: The subject device demonstrated equivalency in terms of volume measurement feature (EDV and ESV or Vmax and Vmin) and strain measurement feature (Global Area Change Ratio, Global Longitudinal Strain and Global Circumference Strain).
Right Ventricle Analysis: The subject device demonstrated equivalency in terms of strain measurement feature (Area Change Ratio, Global Longitudinal Strain, Global Circumference Strain). Additionally, the volume measurement feature (EDV/ESV/EF) demonstrated a Correlation coefficient (r) >= 0.90 with n=11 as compared to the predicate function, Vivid E9 (K131514) with GE EchoPAC (K120221).
Representative clinical images were also obtained using the 3D WMT features LV analysis, LA analysis, RV analysis and Quad Chamber Tracking. It was concluded that the 3D WMT implemented on the subject device enables the cardiac wall trace (initial contour setting) and the local wall motion tracking, providing wall motion information analysis and display, cardiac volume measurement, cardiac function analysis and display of the three analysis features simultaneously.

Performance Testing - Assessment of Auto-EF:
An assessment of workflow improvement was conducted on a group of three volunteers and it was concluded that the full-assist function for tracing the reduced operation time over that of the predicate device to obtain the EDV/ESV/EF and Global Longitudinal Strain. Additionally, a clinical evaluation of this function was conducted and it was demonstrated that Auto-EF performed as expected in presenting appropriate clinical measurements.

Performance Testing - Assessment of 3D ACM:
A study conducted using a pulsating flow phantom demonstrated that flow volume measurement met performance specifications as expected.

Performance Testing - Assessment of Z-Score Measurement:
A bench study was conducted using previously acquired fetal ultrasound data to demonstrate that the subject function calculate and provide the correct Z-score for cardiac structure such as Aortic valve, Pulmonary valve based on the pre obtained value of femur length (FL), biparietal diameter (BPD) or gestational age (GA) using fetal echocardiography.

Performance Testing - Assessment of MPI Measurement:
A bench study was conducted using a Doppler phantom with a water cistern and it was demonstrated that the function can (1) correctly measure velocity at an ROI to provide a graph of time variation of the velocity TIC, by using the 510(k) cleared TDI function, (2) correctly measure the time duration between two points manually indicated on TIC, and (3) calculate MPI correctly from the two time durations designated on TIC.

Performance Testing – Assessment of Mitral Valve Analysis (MVA):
A side-by-side comparison of seventy (70) patients with varying degrees of mitral valve conditions was conducted using a double-intubation protocol to evaluate the basic function and performance of the MVA in vivo, with regard to the visualization of the mitral valve anatomy, surrounding structures, the mitral valve spatial relationship to the and including the annulus, anterior/ posterior leaflets, leaflet segmentation line and commissures. Assessment included evaluation of image quality, measurement, work flow improvement and interoperator variability. Results of the study demonstrated that the subject function is substantially equivalent to the predicate device with regard to all assessment criteria. Additionally, a cardiac phantom was scanned and analyzed by the Aplio i900/MVA software and by a Computed Tomography (CT) system. The MVA software output measurements were compared to equivalent parameters using the CT images. As a result of this study it was determined that the MVA software was able to meet the specified criteria for each of the MVA measurement items as compared to the CT image measurements.

Performance Testing – Assessment of 4D Imaging for 2D Array transducers:
Bench testing was conducted using a phantom to demonstrate that the function correctly depicts the shapes and flow within the phantom. Additionally, clinical images were obtained on volunteers to demonstrate that the function performs as intended.

Additional performance testing, using phantom and volunteer studies, was conducted to assess improvements to existing features including Slice Thickness Control, Auto Volume Measurement, High Frame Rate CHI, 4D CHI, 4D ADF/SMI, iSMI, ECG Sync Acquisition (Shear Wave Elastography), ECG Sync Construction (Sensor 3D), Smart Fusion, 2D WMT (2D Array transducer use), Shear Wave Elastography and Shear Wave Dispersion Map. Results of all these studies demonstrated that the improvements met specifications and performed as intended.

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

• Assessment of 3D WMT: Bench testing and clinical evaluation. For RV analysis, Correlation coefficient (r) >= 0.90 with n=11. Conclusion: The 3D WMT implemented on the subject device enables cardiac wall trace, local wall motion tracking, wall motion information analysis and display, cardiac volume measurement, cardiac function analysis, and simultaneous display of three analysis features.
• Assessment of Auto-EF: Workflow improvement assessment with 3 volunteers, clinical evaluation. Key result: Full-assist function for tracing reduced operation time, performed as expected in presenting appropriate clinical measurements.
• Assessment of 3D ACM: Bench study using a pulsating flow phantom. Key result: Flow volume measurement met performance specifications.
• Assessment of Z-Score Measurement: Bench study using previously acquired fetal ultrasound data. Key result: Correct Z-score calculation for cardiac structures based on pre-obtained values.
• Assessment of MPI Measurement: Bench study using a Doppler phantom with water cistern. Key results: Correct velocity measurement at ROI using TDI, accurate time duration measurement between two points, and correct MPI calculation.
• Assessment of Mitral Valve Analysis (MVA): Side-by-side comparison of 70 patients, cardiac phantom study with CT comparison. Key result: Subject function substantially equivalent to predicate regarding image quality, measurement, workflow, and interoperator variability; met specified criteria compared to CT measurements.
• Assessment of 4D Imaging for 2D Array transducers: Bench testing with phantom, clinical images on volunteers. Key result: Correct depiction of shapes and flow in phantom; performed as intended in clinical images.
• Additional performance testing of existing features (Slice Thickness Control, Auto Volume Measurement, High Frame Rate CHI, 4D CHI, 4D ADF/SMI, iSMI, ECG Sync Acquisition (Shear Wave Elastography), ECG Sync Construction (Sensor 3D), Smart Fusion, 2D WMT (2D Array transducer use), Shear Wave Elastography, Shear Wave Dispersion Map): Phantom and volunteer studies. Key result: Improvements met specifications and performed as intended.

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

Correlation coefficient (r) >= 0.90 (for RV analysis in 3D WMT)

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

K163702, K030455, K131514, K120221, K140729, K162269, K062247

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

Not Found

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

Not Found

Regulation Number and Section

§ 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.

Summary

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

Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

January 11, 2018

Re: K173090

Trade/Device Name: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 20, 2017 Received: December 21, 2017

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and

Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K173090

Device Name

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4

Indications for Use (Describe)

The Diaqnostic 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 usinq ultrasound and to provide image information for diaqnosis in the followinq 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)

كا Prescription Use (Part 21 CFR 801 Subpart D)

• Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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Transducer:

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

Clinical Application	Mode of Operation																				Other [Note]
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
(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT
Ophthalmic
Fetal	P	P	P		P	2	P	P	P		P			P		P	P	P	P	P	P			6,8
Abdominal	P	P	P	P	P	2,3	P	P	P		P		P	P	P	P	P	P	P	P	P	P		4,5,6,7,8
Intra-operative (Abdominal)	P	P	P		P	2	P	P			P			N						P
Intra-operative (Neuro)
Laparoscopic	P	P	P		P	2	P	P			P		P	P
Pediatric	P	P	P	P	P	2,3	P	P			P			P		P	P	P	P	P	P	P		6,8
Small Organ (Note 1)	P	P	P		P	2	P	P	P	P	P		P	P	P					P	P	P		6
Neonatal Cephalic	P	P	P	P	P	3	P				P
Adult Cephalic	P	P	P	P	P	3					P			N		N					N			6
Trans-rectal	P	P	P		P	2	P	P			P		P	P	N	P	P				P	P		8
Trans-vaginal	P	P	P		P	2	P	P			P		P	P	N	P	P				P	P		8
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P		P	2	P	P	P	P	P		P	P						P	P	P		6
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P	P	P		P	P						P	P	P		6
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P				P	P				N	N				N		P	7, 8,9(N),10(N)
Cardiac Pediatric	P	P	P	P	P	3	P				P	P				N	N						P	7,8,9(N), 10(N)
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P					P				N	N						P	8, 10 (N), 11 (N)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	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: K163702 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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Transducer: PSI-30BX

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

Clinical Application Mode of Operation

Clinical Application	Mode of Operation																			Other	[Note]
Specific
(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D
(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P				P			P							P	N		6(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P				P			P							P	N		6(N)
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P				P
Adult Cephalic	P	P	P	P	P	3					P			N							N			6(N)
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		N							N		P	7
Cardiac Pediatric	P	P	P	P	P	3	P				P	P		N							N		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: K163702 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

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Transducer: PSI-70BT

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

Clinical Application Mode of Operation

| Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Micro Pure | Apli Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|---------------------------------|---|---|-----|-----|---------------|----------------------|-------------------|------------|-----------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 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: K163702 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

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Transducer:

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	awa	വന്താ	oldor Dopple	ğiəədə) pəuiquq	uisis urgunisia.	ərin qalında və qalınmışdır. Bu və bir və qalınmışdır. Bu və bir və qalınmışdır. Bu və bir və qalınmışdır. Bu və bir və qalınmışdır. Bu və bir və qalınmışdır. Bu və bir və b	icroPorc	MAMM	Power	IQJ	វិបត្តិកំពង់ច្រើននៅ	(FOA)IM	hear wave	ਰ	and on supportu	SITS	STCCColor	0) علاق 1188 1188 1188 1188 1188 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118	uoisn	ល់ពិនថ្មីរួមស្រី ជាន់យ	LINM az	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P				P			P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	b	P	P	P	3	P				P			P
Small Organ (Note 1)
Neonatal Cephalic	P	b	b	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
Cardiac Pediatric	P	P	P	P	P	3	P				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: K163702 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

7

PST-30BT 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 | Combined (Specify) * | Precision Imaging | Micro Pure | Apli Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] |
|------------------------------------------------|---|---|-----|-----|---------------|----------------------|-------------------|------------|-----------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|--------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 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 | | | | | | | | | | | | | |
| 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: K163702 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

8

PST-50BT Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

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
(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	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: K163702 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

PSI-30VX Transducer:

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

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Micro Pure | 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 | N | N | N | N | N | 3 N | N | | N | | | N | | N | N | | N | N | | | | 7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | 3 N | N | | N | | | N | | N | N | | N | N | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | 3 N | N | | N | | | | N | | | | | | N | | | | |
| 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 | | | N | N | | | | | | | | N | 7,8,9,10 |
| Cardiac Pediatric | N | N | N | N | N | 3 N | N | | N | N | | | N | N | | | | | | | | N | 7,8,9,10 |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |

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

10

PSI-40VX Transducer:

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

Clinical Application Mode of Operation

| Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | 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 | N | N | N | | N | 2 | | | | | N | | | N | | N | N | | | | | | | |
| Abdominal | N | N | N | N | N | 3 | N | | | | N | | | N | | N | N | | | | N | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | 3 | N | | | | N | | | N | | 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 | N | | | | | | N | 7,8,9,10 |
| Cardiac Pediatric | N | N | N | N | N | 3 | N | | | | N | N | | | | N | N | | | | | | N | 7,8,9,10 |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: 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; BD/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

11

PSI-50VX Transducer:

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

Clinical Application Mode of Operation

Contract Concession Comers of
Specific
(Tracks 3)	B	M	ama	ama				ang ild		MA M8	Power	IQI		AQA)IM		ਰ		STIC	TIC Colo	DE 1.18m	uoisn		LINA d	[Note]
Other
					oldor Doppie	iləədə) pərqqur	นเรียน] แบบริเวอ.		licro Pure				រុជមាតិ		әлем теәү		ological cological					oitsgiven 118m
Ophthalmic
Fetal	N	N	N		N	2					N			N		N	N
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	3	N				N			N		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	N						N	7,8,9,10
Cardiac Pediatric	N	N	N	N	N	3	N				N	N				N	N						N	7,8,9,10
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

Transducer: PVI-475BT

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

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other
[Note] |
|------------------------------------------------|------------------------|---|-----|-----|---------------|----------------------|-------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|-----------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | | P | | P | 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: K163702 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

13

Transducer: PVI-475BX

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

Clinical Application	Mode of Operation
----------------------	-------------------

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision Imaging	Combined (Specify) *	Micro Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D	3D Color
(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal	P	P	P	P	P	P	2	P	P		P		P					P
Abdominal	P	P	P	P	P	P	2	P	P		P	P	P	P	P				P	P	P		4,5,6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	2	P	P		P		P					P	P	P	P		6
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (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: K163702 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

14

Transducer: PVT-482BT

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

Clinical Application	Mode of Operation
----------------------	-------------------

Clinical Application	Mode 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	N	N	N		N	2	N	N		N				N				N			N			6
Abdominal	N	N	N		N	2	N	N		N				N				N	N	N				6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	2	N	N		N				N				N	N	N				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: 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

15

PVT-375BT Transducer:

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

	Clinical Application Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color Doppler	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	P	P	P	P	P	2	P	P		P	P		P					P
Abdominal	P	P	P	P	P	2	P	P	P	P	P	P	P	P				P	P	P	P		4, 5, 6, 7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P		P	P		P					P	P	P	P		6
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventiona
I)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K163702 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

PVT-375SC Transducer:

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Precision Imaging
Combined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D
(Volume color)	3D Color
STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other [Note]
Ophthalmic
Fetal	P	P	P	P	2	P	P	P		P							P				6
Abdominal	P	P	P	P	2	P	P	P		P	P	P	P				P	P	P		4,5,6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P		P							P	P	P		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: K163702 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

PVT-382BT Transducer:

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

Clinical Application
Specific

     |  |  |  |  | - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - |  |  |  |  |  |  |  |  |  |  |

| 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 | P | P | | 6 |
| 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 | 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: K163702 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

18

PVT-674BT Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D
(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other [Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P			P			P				P			P
Abdominal	P	P	P		P	2	P	P			P			P				P			P		7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	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: K163702 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

19

PVT-675MVL Transducer:

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

Clinical Application	Mode of Op
----------------------	------------	--

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	ama	ama	aller the production of the production of the production of the cours of the course of the cours of the contribution of the cours of the contribution of the contribution of t	qisədçi (səsinə məşğul	นเชิหนน แบบรเวอ	ərindən ildə və və ildə və və və və və və və və və və və və və və və və və və və və və və və və və və və və və və və və və və və və	Micro Pure	MA ME	www.	IQI	រុជមាន១០នេះនាង	(ACA)IM	әлем теәү		and sology af	SITS	STCCCColo	met them	uo isn	DITERIAEN TIEW	LINM Q	[Note]
Other
Ophthalmic
Fetal	P	b	P		P	2	P	P			P			P		P	b	P	P					8
Abdominal	P	P	P		P	2	P	P			P			P		P	P	P	P					8
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P			P			P		b	P	b	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: K163702 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

20

PVT-675MVS Transducer:

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

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other [Note] | |
|------------------------------------------------|-------------------|---|---|-----|-----|---------------|----------------------|-------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|--------------|--|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | N | N | N | N | N | 2 | N | N | N | | N | | N | | N | N | N | N | N | | | | | 8 | |
| Abdominal | | N | N | N | N | N | 2 | N | N | N | | N | | N | | N | N | N | N | N | | | | | 8 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | 2 | N | N | N | | N | | N | | N | N | N | N | N | | | | | 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: N/A Prescription Use Only (Per 21 CFR 801.109)

Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

21

PVT-681MVL Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K163702 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-712BT Transducer:

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

Clinical Application
Specific
/ 1 - 1 - 1 - 1 -	12 2 2 0 0 0 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2

| Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Smart Navigation | Fusion | 2D WMT | Other | [Note] |
|--------------------------------|---|---|-----|-----|---------------|----------------------|-------------------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|------------------|--------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | P | | | | | | P | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | | P | | | P | | | | | | P | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | 2 | 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: K163702 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-745BTF Transducer:

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

Clinical Application	Mode of Op
----------------------	------------

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Apli Pure	Micro Pure	Power	TDI	Elastography	SMI(ADF)	4D	3D Color
(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other [Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P							P		P			7
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P	P		N					P
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	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: K163702 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-745BTH Transducer:

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

Clinical Application	Mode of Op
----------------------	------------

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	SMI(ADF)	Shear wave	4D
(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P	P										P			7
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P	P	P			N							P
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P	P			P							P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K163702 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

25

PVT-745BTV Transducer:

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

Clinical Application	Mode of Operation
----------------------	-------------------

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	SMI(ADF)	Shear wave	4D
(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P	P		P			P					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: K163702 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

26

PVT-781VT Transducer:

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

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | Note |
|------------------------------------------------|---|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | | P | | | | | | | | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | P | P | P | | P | 2 | P | P | | P | | P | P | N | | | | | | P | P | | | 6 |
| Trans-vaginal | P | P | P | | P | 2 | P | P | | P | | P | P | N | | | | | | 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: K163702 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-781VTE Transducer:

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

Clinical Application	Mode of O
----------------------	-----------

Clinical Application				Mode of Operation
Specific
(Tracks 3)	B	M	awa	ama	plations.	iləsinin cinsinə aid bitki nö	นเซียน] นอเรเวอ	ang ind	Micro Pure	MAMM	Power	IQI	បុប នរដ្ឋាន ប្រជាជន ជា ទ	"H(A)IIM	Shear wave	ਰ	a solo suppo de	STIC	STIC Colo	الا الاستقل التي تركيب المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل التقابل المنتقل المنتقل المنتقل المنتق	uo isn	DIJERIAEN TIEUI	LINA d	[Note]
Other
Ophthalmic
Fetal
Abdominal	P	P	P		b	2	P	b			P			P										7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	b	P	P		P	2	P	P			P		P	P	N						Р	P		6
Trans-vaginal	P	P	P		P	2	P	P			P		P	P	N						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: K163702 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

PVL-715RST Transducer:

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

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | Mode of Operation
B | M | PWD | CWD | Color Doppler | 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 | | 6 | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K163702 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

Transducer: PLI-1205BX

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

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Smart Navigation | Fusion | 2D WMT | Other [Note] |
|------------------------------------------------|---|---|-----|-----|---------------|----------------------|-------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|------------------|--------|--------|--------------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | | | | | | | | | | | | 7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | P | P | P | | P | P | P | | | | | P | P | P | | 6 |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | P | P | | P | P | | | | | | P | P | P | | 6 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | 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 | | | | | | 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: K163702 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

Transducer: PLI-2002BT

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

Clinical Application

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

31

Transducer: PLI-2004BX

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

Clinical Application Mode of Operation

| Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | 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 | P | 2 | 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 | | 6 | |
| Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | P | P | 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 | P | 2 | 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: K163702 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

PLT-704SBT Transducer:

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

Clinical Application	Mode of Op
----------------------	------------

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K163702 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

33

Transducer: PLT-705BT

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	Precision Imaging	Combined (Specify) *	Micro Pure	Apli Pure	BEAM	Power	Elastography	SMI(ADF)	Shear wave	4D
(Volume color)	3D Color
(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P		P		N						N				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
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
Musculo-skeletal (Superficial)	P	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	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: K163702 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

PLT-705BTF Transducer:

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

Clinical Application	Mode of O₂
----------------------	------------

Clinical Application	Mode of Operation
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
(Volume color)	3D 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			N						P
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P		P			N						P
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

35

PLT-705BTH 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 | Combined (Specify) * | Precision Imaging | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D
(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] | |
|------------------------------------------------|---|---|-----|-----|---------------|----------------------|-------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----------------------|----------|------|------------|----------|--------|------------------|--------|-------|--------|--|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | | P | | N | N | | | | | P | | P | | | | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | | P | | P | | N | N | | | | | P | | P | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | | |

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

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

36

PLI-705BX Transducer:

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

Clinical Annlication -Mode of Oneration

ியின் புறந்துவேறு	MUUS UI
Specific
(Tracks 3)	B	M	ama	ama				ildi Pure		MA M8	ower	IQI		(FICIA)IM		ਰ	Color	STIC	TIC Clobo	metism	uo isn		TMW d	Other
[Note]
					player polo	iiəədç) bəniqmə	นรีหน้า แบรรเวอ.		licro Pure				קישורים חיצוניים		әлем леәү		mentone					DITERIARN 11811
Ophthalmic
Fetal
Abdominal	N	N	N		N	2	N	N		N	N			N						N	N			6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	N	N	N		N	2	N	N		N	N			N						N	N			6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	N	N	N		N	2	N	N		N	N			N						N	N			6
Musculo-skeletal (Superficial)	N	N	N		N	2	N	N		N	N			N						N	N			6
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	N	N	N		N	2	N	N		N	N			N						N	N			6
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)

Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

37

PLT-1005BT Transducer:

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

Clinical Application Mode of Operation

| Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | 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 | P | P | P | | P | 2 | P | P | | P | | | | | | | | | | | | | 7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | | P | P | P | P | P | | | | P | P | P | | 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 | | |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | | 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 | P | P | | 6 | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K163702 Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

38

PLT-1202BT Transducer:

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

Clinical Application	Mode of O
----------------------	-----------

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
Intra-operative (Abdominal)	N	N	N	N	N	2	N	N						N					N	N			6
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	N	N	N	N	N	2	N	N				N		N					N	N			6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	N	N	N	N	N	2	N	N				N		N					N	N			6
Musculo-skeletal (Superficial)	N	N	N	N	N	2	N	N				N		N					N	N			6
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	N	N	N	N	N	2	N	N		N	N		N	N					N	N
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)

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-1204BT Transducer:

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

Clinical Application	Mode of O
----------------------	-----------

Clinical Application	Mode 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
(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P		P			N					N					7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P		P	P	P	P	P	P				P
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
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P		P	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	P	P				P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K163702 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

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 | Combined (Specify) * | Precision Imaging | Micro Pure | Apli Pure | BEAM | Power | TDI | SMI(ADF) | Elastography | 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) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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: K163702 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

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

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

Note 1 Small organ includes thyroid, breast and testicle

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

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

Note 8 Shadow Glass

Note 9 3D Wall Motion Tracking

Note 10 3D ACM

42

Transducer: PET-512MD

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

Clinical Application Mode of Operation

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging
Combined (Specify) * | Micro Pure | BEAM | Power | Elastography | TDI | Shear wave | SMI(ADF) | 4D | 3D Color
(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|---|---|-----|-----|---------------|-------------------------------------------|------------|------|-------|--------------|-----|------------|----------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | | | | | P | | | | | | | | | | P | |
| 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: K163702 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

PEI-512VX Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation Specific Other [Note] and CMD B BBAM olor Dopple OWEL LINM Q (Tracks 3) A(A)IIM រុជមានចំណុះន ARM IRƏL mart 3F UOISI ğişədç) pəuiqur iganI noisiae icro Purce olo Colo DITERIARN 1.18U li Pure ​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​ 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

N

N N N 8,10,11

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

N N N N N 3 N

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

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

Note 4 ATI

Note 5 Tissue Intensity Analysis

Note 6 Sensor3D

Intravascular (Cardiac) Trans-esoph. (Cardiac)

Intra-cardiac Other (Specify) Peripheral vessel

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

Transducer: PET-805LA

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

Mode of Operation Clinical Application

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | Precision Imaging | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D
(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Smart Navigation | Fusion | 2D WMT | Other | [Note] |
|------------------------------------------------|-------------------|---|---|-----|-----|---------------|----------------------|-------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----------------------|----------|------|------------|----------|------------------|--------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | | P | P | P | P | | 2 | P | P | | P | | | | | | | | | | | | | 7 | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | 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: K163702 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

PC-20M Transducer:_

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

Clinical Application		Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Precision Imaging
Combined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	Shear wave	SMI(ADF)	4D
(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal
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: K163702 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

Toshiba America Medical Systems, Inc.

510(k) Premarket Notification Aplio i900, i800, i700 V2.1 Diagnostic Ultrasound System

System: Aplio i900, i800, i700, i600 V2.4 Transducer: PC-50M

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	Apli Pure	BEAM	Power	Elastography	Shear wave	SMI(ADF)	4D
(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
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: K163702 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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Image /page/47/Picture/0 description: The image shows the logo for Toshiba Medical. The words "TOSHIBA" and "MEDICAL" are stacked on top of each other. Both words are written in a bold, sans-serif font and are colored red.

510(k) SUMMARY

• 1. SUBMITTER'S NAME: Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550
• OFFICIAL CORRESPONDENT 2. Naofumi Watanabe
• 3. ESTABLISHMENT REGISTRATION: 9614698

4. CONTACT PERSON:

Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive Tustin, CA 92780 [phone]

• 5. Date Prepared: December 20, 2017

6. TRADE NAME(S):

Diagnostic Ultrasound System Aplio i900 Model TUS-AI900 Software Version V2.4 Aplio i800 Model TUS-AI800 Software Version V2.4 Aplio i700 Model TUS-AI700 Software Version V2.4 Aplio i600 Model TUS-AI600 Software Version V2.4

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]

Image /page/47/Picture/17 description: The image shows the Canon Group logo. The word "Canon" is in red, and the words "Canon Group" are in black. The word "Canon" is in a bold, sans-serif font, and the words "Canon Group" are in a smaller, sans-serif font.

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9. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
Aplio i900/i800/i700 Diagnostic
Ultrasound System, V2.1
(Main Predicate Device)	Toshiba America
Medical Systems	K163702	May 30, 2017
Boris Platform Ultrasound System	Philips Ultrasound, Inc.	K030455	March 13, 2003
Vivid E9	GE Healthcare	K131514	July 12, 2013
GE EchoPAC	GE Healthcare	K120221	March 30, 2012
Aplio Artida (SSH-880CV), V3.2	Toshiba America
Medical Systems	K140729	May 23, 2014
Voluson E8	GE Healthcare	K162269	October 3, 2016
HD11	Philips Ultrasound, Inc.	K062247	August 18, 2006

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-A1600, V2.4 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 20 MHz.

12. INDICATIONS FOR USE:

The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-Al700 and Aplio i600 Model TUS-Al600 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-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, Diagnostic Ultrasound System, V2.1, K163702, marketed by Toshiba America Medical Systems. The Aplio i900 Model TUS-A1900, Aplio i800 Model TUS-Al800, Aplio i700 Model TUS-A1700 and Aplio i600 Model TUS-Al600, V2.4 function in a manner similar to and is intended for the same use as the predicate devices. The subject device is a compact diagnostic ultrasound system that implements the latest technologies.

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| Device | Aplio
i900/i800/
i700/i600
V2.4 | Aplio
i900/i800/
i700 (V2.1) | Artida
V3.2 | Vivid
E9/Echo
PAC | Voluson
E8 | Boris
Platform
Ultrasound
System | HD11 | Comment |
|----------------------------------|------------------------------------------|------------------------------------|-----------------------|-------------------------|---------------|-------------------------------------------|---------|-----------------------------------------------|
| 510(k)
Clearance
Number | Subject
Device | K163702
(Main
Predicate) | K140729 | K131514/
K120221 | K162269 | K030455 | K062247 | |
| 3D
Wall
Motion
Tracking | Yes* | No | Yes
LV
Analysis | RV
Analysis | | | | *LA and
RV analysis
are new
features |
| Z-Score | Yes | No | | | Yes | | | |
| Mitral
Valve
Analysis | Yes | No | | | | Yes | | |
| MPI | Yes | No | | | | | Yes | |

Improvements to previously cleared functions:

| Device | Aplio
i900/i800/i700/i600
V2.4 | Aplio
i900/i800/i700
(V2.1) | Comment |
|---------------------------------------------------|--------------------------------------|-----------------------------------|------------------------------------------------------------|
| Thin Slice Imaging | Yes | Yes | Slice Thickness Control
Feature Improvement(s) |
| Auto Volume Measurement | Yes | Yes | Feature
Improvement(s) |
| CHI | Yes | Yes | High Frame Rate/4D
Feature Improvement(s) |
| SMI | Yes | Yes | iSMI/4D
Feature Improvement(s) |
| ADF | Yes | Yes | 4D
Feature Improvement(s) |
| Shear Wave Elastography
(ECG Sync Acquisition) | Yes | Yes | Feature Improvement(s) |
| Sensor 3D
(ECG Sync Construction) | Yes | Yes | Feature Improvement(s) |
| Smart Fusion | Yes | Yes | Feature Improvement(s) |
| 2D WMT | Yes | Yes | Use with 2D Array
transducers
Feature Improvement(s) |
| Shear Wave Elastography | Yes | Yes | New clinical applications |
| Shear Wave Dispersion Map | Yes | Yes | Feature Improvement(s) |
| PSI-30VX | Yes | No | New transducer |
| PSI-40VX | Yes | No | New transducer |

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| Device | Aplio
i900/i800/i700/i600
V2.4 | Aplio
i900/i800/i700/i600
(V2.1) | Comment |
|------------|--------------------------------------|----------------------------------------|----------------|
| PSI-50VX | Yes | No | New transducer |
| PLI-2002BT | Yes | No | New transducer |
| PVT-482BT | Yes | No | New transducer |
| PVT-675MVS | Yes | No | New transducer |
| PLI-705BX | Yes | No | New transducer |
| PLT-1202BT | Yes | No | New transducer |
| PEI-512VX | Yes | No | New transducer |

14. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, NEMA UD 3, NEMA UD 2, and ISO 10993-1 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.

Performance Testing – Assessment of 3D WMT

Multiple studies were performed to confirm that the function of 3D Wall Motion Tracking on the Aplio i900/i800/i700 is substantially equivalent to the predicate devices with regard to the following:

Left Ventricle Analysis: The subject device demonstrated equivalency in terms of volume measurement feature (EDV/ESV/EF) and strain measurement feature (Area Change Ratio, Global Longitudinal Strain, Global Circumference Strain, Global Radial Strain).

Left Atrium Analysis: The subject device demonstrated equivalency in terms of volume measurement feature (EDV and ESV or Vmax and Vmin) and strain measurement feature (Global

Area Change Ratio, Global Longitudinal Strain and Global Circumference Strain).

Right Ventricle Analysis: The subject device demonstrated equivalency in terms of strain measurement feature (Area Change Ratio, Global Longitudinal Strain, Global Circumference Strain). Additionally, the volume measurement feature (EDV/ESV/EF) demonstrated a Correlation coefficient (r) >= 0.90 with n=11 as compared to the predicate function, Vivid E9 (K131514) with GE EchoPAC (K120221).

Representative clinical images were also obtained using the 3D WMT features LV analysis, LA analysis, RV analysis and Quad Chamber Tracking. It was concluded that the 3D WMT implemented on the subject device enables the cardiac wall trace (initial contour setting) and

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the local wall motion tracking, providing wall motion information analysis and display, cardiac volume measurement, cardiac function analysis and display of the three analysis features simultaneously.

Performance Testing - Assessment of Auto-EF

An assessment of workflow improvement was conducted on a group of three volunteers and it was concluded that the full-assist function for tracing the reduced operation time over that of the predicate device to obtain the EDV/ESV/EF and Global Longitudinal Strain. Additionally, a clinical evaluation of this function was conducted and it was demonstrated that Auto-EF performed as expected in presenting appropriate clinical measurements.

Performance Testing - Assessment of 3D ACM

A study conducted using a pulsating flow phantom demonstrated that flow volume measurement met performance specifications as expected.

Performance Testing - Assessment of Z-Score Measurement

A bench study was conducted using previously acquired fetal ultrasound data to demonstrate that the subject function calculate and provide the correct Z-score for cardiac structure such as Aortic valve ,Pulmonary valve based on the pre obtained value of femur length (FL), biparietal diameter (BPD) or gestational age (GA) using fetal echocardiography.

Performance Testing - Assessment of MPI Measurement

A bench study was conducted using a Doppler phantom with a water cistern and it was demonstrated that the function can (1) correctly measure velocity at an ROI to provide a graph of time variation of the velocity TIC, by using the 510(k) cleared TDI function, (2) correctly measure the time duration between two points manually indicated on TIC, and (3) calculate MPI correctly from the two time durations designated on TIC.

Performance Testing – Assessment of Mitral Valve Analysis (MVA)

A side-by-side comparison of seventy (70) patients with varying degrees of mitral valve conditions was conducted using a double-intubation protocol to evaluate the basic function and performance of the MVA in vivo, with regard to the visualization of the mitral valve anatomy, surrounding structures, the mitral valve spatial relationship to the and including the annulus, anterior/ posterior leaflets, leaflet segmentation line and commissures. Assessment included evaluation of image quality, measurement, work flow improvement and interoperator variability. Results of the study demonstrated that the subject function is substantially equivalent to the predicate device with regard to all assessment criteria. Additionally, a cardiac phantom was scanned and analyzed by the Aplio i900/MVA software and by a Computed Tomography (CT) system. The MVA software output measurements were compared to equivalent parameters using the CT images. As a result of this study it was determined that the MVA software was able to meet the specified criteria for each of the MVA measurement items as compared to the CT image measurements.

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Performance Testing – Assessment of 4D Imaging for 2D Array transducers

Bench testing was conducted using a phantom to demonstrate that the function correctly depicts the shapes and flow within the phantom. Additionally, clinical images were obtained on volunteers to demonstrate that the function performs as intended.

Additional performance testing, using phantom and volunteer studies, was conducted to assess improvements to existing features including Slice Thickness Control, Auto Volume Measurement, High Frame Rate CHI, 4D CHI, 4D ADF/SMI, iSMI, ECG Sync Acquisition (Shear Wave Elastography), ECG Sync Construction (Sensor 3D), Smart Fusion, 2D WMT (2D Array transducer use), Shear Wave Elastography and Shear Wave Dispersion Map. Results of all these studies demonstrated that the improvements met specifications and performed as intended.

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

16. CONCLUSION

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-Al600, V2.4 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, acquisition of representative clinical images, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use.