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
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K131514 , K120221 , K163702 , K030455 , K140729 , K162269 , K062247
• Predicate For: K180323 , K182427 , K182679 , K191007

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.

AI/ML Overview

This document describes the Toshiba Medical Systems Corporation Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4, a modified device, and compares it to a predicate device (Aplio i900/i800/i700, V2.1, K163702).

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The device is substantially equivalent to its predicate device and offers several new features and improvements. Acceptance criteria are typically defined by demonstrating substantial equivalence to a legally marketed predicate device and meeting performance specifications through testing.

Specific performance assessments for new and improved features include:

Feature/Metric	Acceptance Criteria (Demonstrated Equivalency/Performance)	Reported Device Performance
3D Wall Motion Tracking (LV Analysis)	Equivalency in volume measurement (EDV/ESV/EF) and strain measurement (Area Change Ratio, Global Longitudinal Strain, Global Circumference Strain, Global Radial Strain) compared to predicate devices.	Demonstrated equivalency in volume and strain measurements. The implemented 3D WMT features enabled cardiac wall trace, local wall motion tracking, wall motion information analysis and display, cardiac volume measurement, and cardiac function analysis and display of three analysis features simultaneously.
3D Wall Motion Tracking (LA Analysis)	Equivalency in volume measurement (EDV/ESV or Vmax/Vmin) and strain measurement (Global Area Change Ratio, Global Longitudinal Strain and Global Circumference Strain) compared to predicate devices.	Demonstrated equivalency in volume and strain measurements. The implemented 3D WMT features enabled cardiac wall trace, local wall motion tracking, wall motion information analysis and display, cardiac volume measurement, and cardiac function analysis and display of three analysis features simultaneously.
3D Wall Motion Tracking (RV Analysis)	Equivalency in strain measurement (Area Change Ratio, Global Longitudinal Strain, Global Circumference Strain) and a Correlation coefficient (r) >= 0.90 with n=11 for volume measurement (EDV/ESV/EF) to the predicate function (Vivid E9, K131514 with GE EchoPAC, K120221).	Demonstrated equivalency in strain measurements and a correlation coefficient (r) >= 0.90 for volume measurement. The implemented 3D WMT features enabled cardiac wall trace, local wall motion tracking, wall motion information analysis and display, cardiac volume measurement, and cardiac function analysis and display of three analysis features simultaneously.
Auto-EF	Demonstrated reduction in operation time for tracing (full-assist function) and appropriate clinical measurements.	Full-assist function for tracing showed reduced operation time compared to the predicate device to obtain EDV/ESV/EF and Global Longitudinal Strain. Clinical evaluation demonstrated appropriate clinical measurements.
3D ACM	Function correctly measures flow volume and meets performance specifications.	Pulsating flow phantom study demonstrated that flow volume measurement met performance specifications as expected.
Z-Score Measurement	Function correctly calculates and provides the correct Z-score for cardiac structures (Aortic valve, Pulmonary valve) based on pre-obtained values of femur length (FL), biparietal diameter (BPD), or gestational age (GA) using fetal echocardiography.	Bench study using previously acquired fetal ultrasound data demonstrated correct Z-score calculation for cardiac structures based on provided parameters.
MPI Measurement	Function correctly measures velocity at an ROI to provide a graph of time variation of the velocity TIC, correctly measures time duration between two points on TIC, and correctly calculates MPI from these durations.	Bench study using Doppler phantom demonstrated correct velocity measurement and TIC generation, correct measurement of time duration, and correct MPI calculation.
Mitral Valve Analysis (MVA)	Function demonstrates basic function and performance in vivo regarding visualization of mitral valve anatomy, surrounding structures, spatial relationship, and components (annulus, leaflets, segmentation line, commissures). Acceptance also includes image quality, measurement, workflow improvement, and interoperator variability. Measurement items to meet specified criteria compared to CT images.	Side-by-side comparison of 70 patients showed substantial equivalency in basic function, performance, visualization, image quality, measurement, workflow improvement, and interoperator variability. Cardiac phantom study confirmed MVA software met specified criteria for measurement items compared to CT image measurements.
4D Imaging for 2D Array Transducers	Function correctly depicts shapes and flow within a phantom and performs as intended in clinical images on volunteers.	Bench testing with a phantom demonstrated correct depiction of shapes and flow. Clinical images on volunteers confirmed the function performs as intended.
Improvements to Existing Features	Improvements to 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 meet specifications and perform as intended.	Studies demonstrated that these improvements met specifications and performed as intended through phantom and volunteer studies.

2. Sample Size Used for the Test Set and Data Provenance

• 3D Wall Motion Tracking (RV Analysis): n=11 for the correlation coefficient for volume measurement.
• Mitral Valve Analysis (MVA): Seventy (70) patients were included in a side-by-side comparison study. A cardiac phantom was also used.
• Auto-EF: A group of three volunteers for workflow improvement assessment. A clinical evaluation was also conducted (sample size not specified).
• Z-Score Measurement: Previously acquired fetal ultrasound data. (Sample size not specified)
• 4D Imaging for 2D Array transducers: Phantom studies and volunteer studies (number of volunteers not specified).
• Improvements to existing features: Phantom and volunteer studies (sample sizes not specified).

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" for most studies. However, the mention of "previously acquired fetal ultrasound data" for Z-Score implies retrospective data for that specific test. The mention of "volunteers" and "patients" suggests prospective data for other tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not explicitly describe an MRMC comparative effectiveness study where human readers improve with AI assistance. The testing focuses on the device's performance against predicate devices or pre-defined performance metrics, but not on human-AI collaboration.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The studies conducted for Auto-EF, 3D ACM, Z-Score Measurement, and MPI Measurement appear to be standalone tests of the algorithm's performance against defined criteria or phantoms. While Auto-EF also involved an assessment of workflow improvement with volunteers, the core performance checks for these features seem to be standalone.

7. The Type of Ground Truth Used

• 3D Wall Motion Tracking (RV Analysis): Comparison to the predicate function (Vivid E9, K131514 with GE EchoPAC, K120221).
• Auto-EF: "Appropriate clinical measurements" as expected.
• 3D ACM: Performance specifications for flow volume measurement using a pulsating flow phantom.
• Z-Score Measurement: Pre-obtained values of femur length (FL), biparietal diameter (BPD), or gestational age (GA) using fetal echocardiography.
• MPI Measurement: Correct measurement of velocity and time durations in a Doppler phantom, and correct MPI calculation according to predefined methods.
• Mitral Valve Analysis (MVA):
  • In vivo evaluation: "Basic function and performance" in visualization, measurements, workflow improvement, and interoperator variability using 70 patients.
  • Phantom study: Comparison of MVA software output measurements to equivalent parameters obtained from a Computed Tomography (CT) system.
• 4D Imaging for 2D Array transducers: Correct depiction of shapes and flow in a phantom, and performance "as intended" in clinical images on volunteers.

8. The Sample Size for the Training Set

This information is not provided in the given text. The document describes verification and validation testing, but not details about model training.

9. How the Ground Truth for the Training Set was Established

This information is not provided in the given text, as training set details are absent.

Summary

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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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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PST-30BT Transducer:

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

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

Clinical ApplicationSpecific(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 ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	Shear waveSMI(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 ApplicationSpecific(Tracks 3)	Mode of OperationB	M	PWD	CWD	Color Doppler	Precision ImagingCombined (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 ApplicationSpecific(Tracks 3)	Mode of OperationB	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 ImagingCombined (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 (ConventionaI)
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 ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D(Volume color)	3D ColorSTIC	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 ApplicationSpecific(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 ApplicationSpecific(Tracks 3)	Mode of OperationB	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 ImagingCombined (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 ImagingCombined (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 ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (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 ApplicationSpecific(Tracks 3)	Mode of OperationB	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 ApplicationSpecific(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 ApplicationSpecific(Tracks 3)	Mode of OperationB	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 ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (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 ImagingCombined (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 ApplicationSpecific(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 ImagingCombined (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 ImagingCombined (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 ApplicationSpecific(Tracks 3)	Mode of OperationB	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 ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (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 ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (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 ApplicationSpecific(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 ImagingCombined (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

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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 DiagnosticUltrasound System, V2.1(Main Predicate Device)	Toshiba AmericaMedical 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 AmericaMedical 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	Aplioi900/i800/i700/i600V2.4	Aplioi900/i800/i700 (V2.1)	ArtidaV3.2	VividE9/EchoPAC	VolusonE8	BorisPlatformUltrasoundSystem	HD11	Comment
510(k)ClearanceNumber	SubjectDevice	K163702(MainPredicate)	K140729	K131514/K120221	K162269	K030455	K062247
3DWallMotionTracking	Yes*	No	YesLVAnalysis	RVAnalysis				*LA andRV analysisare newfeatures
Z-Score	Yes	No			Yes
MitralValveAnalysis	Yes	No				Yes
MPI	Yes	No					Yes

Improvements to previously cleared functions:

Device	Aplioi900/i800/i700/i600V2.4	Aplioi900/i800/i700(V2.1)	Comment
Thin Slice Imaging	Yes	Yes	Slice Thickness ControlFeature Improvement(s)
Auto Volume Measurement	Yes	Yes	FeatureImprovement(s)
CHI	Yes	Yes	High Frame Rate/4DFeature Improvement(s)
SMI	Yes	Yes	iSMI/4DFeature Improvement(s)
ADF	Yes	Yes	4DFeature 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 ArraytransducersFeature 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	Aplioi900/i800/i700/i600V2.4	Aplioi900/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.

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.