Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1

• K Number: K163702
• Device Name: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
• Manufacturer: TOSHIBA MEDICAL SYSTEMS CORPORATION
• Date Cleared: 2017-05-30 ( 152 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K161843 , K151451
• Predicate For: K173090

Intended Use

The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700 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 following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small orqans, trans-vaqinal, 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-Al900, Aplio i800 Model TUS-Al800 and Aplio i700 Model TUS-Al700, V2.1 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 20 MHz.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1, based on the provided text:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit numerical acceptance criteria for a novel AI feature. However, it does highlight the performance of the 2D WMT function.

Table of Acceptance Criteria and Reported Device Performance

Criterion Description	Device Performance (2D WMT function) Reported
Substantial equivalence to predicate device for display and calculation of GLS, GCS, GRS, EDV/ESV/EF, and global/segment strain in Polar Map display.	The study concluded that the 2D WMT function is substantially equivalent to the predicate device with regard to the display of GLS, GCS, GRS and EDV/ESV/EF and the calculation/provision of global and segment strain in a Polar Map display.
Workflow Improvement (reduced operation time with 2D WMT full-assist).	Using the 2D WMT full-assist function on the subject device resulted in reduced operation time over that of the predicate device. (Specific quantitative improvement not provided).
Intentional performance for cardiac wall trace, local wall motion tracking, wall motion information analysis/display, cardiac volume measurement, and cardiac function analysis.	Representative clinical images were obtained, and it was concluded that the 2D WMT implemented on the subject device performs as intended. More specifically, it enables the cardiac wall trace (initial contour setting), the local wall motion tracking and provides wall motion information analysis and display, cardiac volume measurement, and cardiac function analysis.
Measurement accuracy/precision for key cardiac parameters (EDV, ESV, Long. Strain Inner, Radial Strain, Total and Circumferential Strain Inner).	In a 10-patient study, the measurement of major parameters (EDV, ESV, Long. Strain Inner, Radial Strain, Total and Circumferential Strain Inner) had a less than 11% coefficient of variation. The initial contour trace lines created by clinicians showed little differences, attributed to ultrasound image border recognition, read-out conditions, and image frame selection differences.

Study Details

This document describes a performance study conducted to support the substantial equivalence claim, specifically focusing on the new "2D WMT" feature.

1. Sample size used for the test set and the data provenance:

   • Sample Size: 10 patients.
   • Data Provenance: Not specified (e.g., country of origin). It is also not specified whether the data was retrospective or prospective, though the description "representative clinical images were obtained" suggests prospective data collection or selection for the purpose of this validation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Three (3) clinicians.
   • Qualifications of Experts: Not specified beyond "clinicians."

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not explicitly stated. The text mentions "initial contour trace lines created by the clinicians showed little differences," implying that the 3 clinicians each performed measurements and their results were compared, rather than a formal adjudication process to establish a single "ground truth" per case. The low coefficient of variation suggests a high degree of agreement among them.

4. 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:

   • A comparative effectiveness study was conducted regarding workflow improvement. It was concluded that using the 2D WMT full-assist function resulted in reduced operation time over that of the predicate device.
   • Effect Size: The document states that the new feature "resulted in reduced operation time" but does not provide a quantitative effect size (e.g., percentage reduction in time, average time saved).

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • The term "2D WMT full-assist function" suggests that this feature is intended to assist a human operator. The evaluation of reduced operation time implies a human-in-the-loop scenario. There is no explicit mention of a standalone algorithm performance study without human interaction in this document. The "initial contour setting" is described as being "created by the clinicians," further supporting that it's not a fully autonomous AI system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth appears to be based on expert consensus/measurement by three clinicians. The measurements of "major parameters EDV, ESV, Long. Strain Inner, Radial Strain, Total and Circumferential Strain Inner" by these clinicians were used for comparison and to assess variability.

7. The sample size for the training set:

   • Not specified. The document primarily details the performance study for the modified device, not the development or training of any AI components. The 2D WMT is mentioned as a "previously cleared feature implemented on subject device" with a "newly implemented" auto initial contour setting. This suggests the "AI" (if any, related to auto contour) was likely trained prior to this submission, and its training data is not discussed here.

8. How the ground truth for the training set was established:

   • Not specified, as the training set details are not provided in this regulatory submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 30, 2017

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

Re: K163702

Trade/Device Name: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 21, 2017 Received: April 25, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D'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)

K163702

Device Name

Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1

Indications for Use (Describe)

The Diaqnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700 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 following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small orqans, trans-vaqinal, 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)

اك 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
----------

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify)	Micro Pure	Apli Pure	Power	BEAM	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	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		4,5,6,7,8
Intra-operative (Abdominal)	P	P	P		P	2	P	P			P								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		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
Trans-rectal	P	P	P		P	2	P	P			P		P	P		P	P				P		8
Trans-vaginal	P	P	P		P	2	P	P			P		P	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 7,8
Cardiac Pediatric	P	P	P	P	P	3	P				P	P											N 7,8
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P					P											N 8
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: K161843 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)

{4}------------------------------------------------

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	Precision ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D(Volume color)	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P			P			P							P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P			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												N 7
Cardiac Pediatric	P	P	P	P	P	3	P			P	P												N 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: K161843 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)

{5}------------------------------------------------

Transducer: PSI-70BT

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	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	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											N 7
Cardiac Pediatric	P	P	P	P	P	3	P			P	P											N 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: K161843 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)

{6}------------------------------------------------

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	Precision Imaging	Combined (Specify) *	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	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												N
Cardiac Pediatric	P	P	P	P	P	3	P		P	P												N
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 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)

{7}------------------------------------------------

PST-30BT 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 PureApli Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	FusionSmart 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										N 7
Cardiac Pediatric	P	P	P	P	P	3			P	P										N 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: K161843 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)

{8}------------------------------------------------

PST-50BT 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) *	Color Doppler	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P		P		P		E
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P		P		P		E
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											N
Cardiac Pediatric	P	P	P	P	P	3					P	P											N
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 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)

{9}------------------------------------------------

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)	B	M	PWD	CWD	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	P	P	P	P	2	P	P		P				P					P
Abdominal	P	P	P	P	2	P	P		P	P	P	P	E					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: K161843 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)

{10}------------------------------------------------

Transducer: PVI-475BX

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

Clinical Application

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	P	P	P		P	2	P	P		P			P						P
Abdominal	P	P	P		P	2	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: K161843 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)

{11}------------------------------------------------

PVT-375BT 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	Precision ImagingCombined (Specify) *	Color Doppler	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
Abdominal	P	P	P	P	2	P	P	P		P	P	P	P	P					P	P	P	4, 5, 6, 7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P		P			P						P	P	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: K161843 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)

{12}------------------------------------------------

Transducer: PVT-375SC

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	P	P	P	P	P	2	P	P		P		P							P				6
Abdominal	P	P	P	P	P	2	P	P		P	P	P	P	P					P	P	P		4,5,67
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P		P		P							P	P	P		6
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 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)

{13}------------------------------------------------

PVT-382BT 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								Other	[Note]
Specific(Tracks 3)	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Shear wave	SMI(ADF)	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT
Ophthalmic
Fetal	P	P	P	P	P	2	P	P		P	P		P					P	P	P		6
Abdominal	P	P	P	P	P	2	P	P		P	P		P					P	P	P		6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	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: K161843 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)

{14}------------------------------------------------

PVT-674BT 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	Precision ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	TDI	Elastography	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
Abdominal	P	P	P	P	2	P	P		P		P						P			7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P		P		P						P
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 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)

{15}------------------------------------------------

PVT-675MVL 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	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	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	P	P	P	P		8
Abdominal	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	P	P	P	P		8
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P	P	P	P	P	P	P	P	P	P	P	P		8
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 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)

{16}------------------------------------------------

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	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												7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	2	P	P		P		P	P	P	P	P						8
Trans-vaginal	P	P	P	P	2	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: K161843 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)

{17}------------------------------------------------

PVT-712BT 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																	Other	[Note]
	B	M	PWD	CWD	Color Doppler	Precision ImagingCombined (Specify) *	Micro PureApli Pure	BEAMPower	TDIElastography	SMI(ADF)	Shear wave	4D(Volume color)	3D ColorSTIC	STIC Color	Smart 3D	FusionSmart Navigation	2D WMT
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P	P						P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P	P						P
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	2	P	P	P	P						P
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 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)

{18}------------------------------------------------

PVT-745BTF 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	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P 2	P	P		P				P					P				7
Intra-operative (Abdominal)	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
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: K161843 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)

{19}------------------------------------------------

PVT-745BTH 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																					Other	[Note]
	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
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					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: K161843 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)

{20}------------------------------------------------

PVT-745BTV 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	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					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
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: K161843 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)

{21}------------------------------------------------

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) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D(Volume color)	3D Color	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	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	6
Trans-vaginal	P	P	P	P	P	2	P	P		P		P	P							P	P	6
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 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)

{22}------------------------------------------------

PVT-781VTE 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	Precision ImagingCombined (Specify) *	Apli Pure	Micro Pure	BEAM	Power	Elastography	TDI	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								7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal		P	P	P	P	2	P	P		P		P	P	P						P	P		6
Trans-vaginal		P	P	P	P	2	P	P		P		P	P	P						P	P		6
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 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)

{23}------------------------------------------------

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)	B	M	PWD	CWD	Precision ImagingCombined (Specify) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	Shear wave	SMI(ADF)	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P2	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		P2	P	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: K161843 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)

{24}------------------------------------------------

Transducer: PLI-1205BX

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	Precision ImagingCombined (Specify) *	Micro Pure	Apli Pure	BEAM	Power	TDI	SMI(ADF)	Elastography	Shear wave	4D(Volume color)	3D ColorSTIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P		P												7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P	P	P		P	P	P					P	P	P		6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P		P	2	P	P	P	P	P		P	P						P	P	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: K161843 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)

{25}------------------------------------------------

Transducer: PLI-2004BX

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

Clinical Application

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation	B	M	PWD	CWD	Color Doppler	Combined (Specify) *	Precision Imaging	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	SMI(ADF)	Shear wave	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal
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		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		6
Musculo-skeletal (Superficial)		P	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	P	2	P	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: K161843 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)

{26}------------------------------------------------

PLT-704SBT 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	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	P	2	P	P		P												7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)		P	P	P	P	P	2	P	P		P	P		P						P
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: K161843 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)

{27}------------------------------------------------

PLT-705BT 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	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
Abdominal		P	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	P	2	P	P	P	P		P		P					P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)		P	P	P	P	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: K161843 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)

{28}------------------------------------------------

PLT-1005BT 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) *	Micro Pure	Apli Pure	BEAM	Power	TDI	Elastography	Shear wave	SMI(ADF)	4D	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P		P														7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
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: K161843 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)

{29}------------------------------------------------

PLT-1204BT 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) *	Micro Pure	Apli Pure	BEAM	Power	TDI	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
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
Musculo-skeletal (Superficial)	P	P	P		P	2	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
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 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)

{30}------------------------------------------------

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)	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
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											N
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: K161843 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)

{31}------------------------------------------------

Transducer: PET-512MD

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

Clinical Application

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation	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 ColorSTIC	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										N
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: K161843 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)

{32}------------------------------------------------

PET-805LA Transducer:

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

Clinical Application Mode of Operation

Clinical Application	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	3D Color(Volume color)	STIC	STIC Color	Smart 3D	Fusion	Smart Navigation	2D WMT	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	P		P													7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic	P	P	P	P	2	P	P		P		P	P	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: K161843 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)

{33}------------------------------------------------

PC-20M 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 DopplerCombined (Specify) *	Precision Imaging	Apli Pure	Micro Pure	BEAM	Power	TDI
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: K161843 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)

{34}------------------------------------------------

Toshiba America Medical Systems, Inc.

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

System: Aplio i900, i800, i700 V2.1 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	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
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: K161843 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)

{35}------------------------------------------------

510(k) SUMMARY

• 1. SUBMITTER'S NAME: Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550
• 2. OFFICIAL CORRESPONDENT Akinori Hatanaka
• ESTABLISHMENT REGISTRATION: 3. 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: April 21, 2017

TRADE NAME(S): 6.

Diagnostic Ultrasound System Aplio i900 Model TUS-Al900 Software Version V2.1 Aplio i800 Model TUS-Al800 Software Version V2.1 Aplio i700 Model TUS-AI700 Software Version V2.1

7. COMMON NAME:

System, Diagnostic Ultrasound

DEVICE CLASSIFICATION: 8.

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/35/Picture/17 description: The image shows the Canon logo. The word "Canon" is in red, and the words "CANON GROUP" are in black below it. The font is sans-serif and bolded.

{36}------------------------------------------------

9. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
Aplio i900/i800/i700 DiagnosticUltrasound System, V2.0	Toshiba AmericaMedical Systems	K161843	September 21, 2016
Aplio 500/400/300 DiagnosticUltrasound System, V6.0	Toshiba AmericaMedical Systems	K151451	July 9, 2016

10. REASON FOR SUBMISSION:

Modification of a cleared device

11. DEVICE DESCRIPTION:

The Aplio i900 Model TUS-Al900, Aplio i800 Model TUS-Al800 and Aplio i700 Model TUS-Al700, V2.1 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 20 MHz.

12. INDICATIONS FOR USE:

The Diagnostic Ultrasound Systems Aplio i900 Model TUS-Al900. Aplio i800 Model TUS-Al800 and Aplio i700 Model TUS-Al700 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculoskeletal (both conventional and superficial) and laparoscopic.

13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Aplio i900/i800/i700, Diagnostic Ultrasound System, V2.0, K161843, marketed by Toshiba America Medical Systems. The Aplio i900 Model TUS-A1900. Aplio i800 Model TUS-A1800 and Aplio i700 Model TUS-A1700. V2.1 function in a manner similar to and is intended for the same use as the predicate device. The subject device is a compact diagnostic ultrasound system that implements the latest technologies.

Device	AplioA500/400/300V6.0	Aplioi900/i800/i700V2.0	Aplioi900/i800/i700V2.1	Comment
510(k)ClearanceNumber	K151451(Predicate)	K161843(Predicate)	This Submission(Subject)
2D WMT	Yes(Auto initialcontour settingis not available)	No	Yes(Auto initialcontour settingis available)	Previously clearedfeature implementedon subject device(Auto initial contoursetting is newlyimplemented in thesubject device)

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 IEC60601-1 (2005). IEC 60601-2-37 (2007). IEC 62304 (2006). AIUM RTD2-2004 Output Display and ISO 10993-1 standards.

{37}------------------------------------------------

15. TESTING

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

Performance Testing - Assessment of Workflow Improvement

The study concluded that the 2D WMT function is substantially equivalent to the predicate device with regard to the display of GLS. GCS. GRS and EDV/ESV/EF and the calculation/provision of global and segment strain in a Polar Map display. Additionally, it was also concluded that using the 2D WMT full-assist function on the subject device resulted in reduced operation time over that of the predicate device.

Performance Testing - Clinical Images

Representative clinical images were obtained and it was concluded that the 2D WMT implemented on the subject device performs as intended. More specifically, it enables the cardiac wall trace (initial contour setting), the local wall motion tracking and provides wall motion information analysis and display, cardiac volume measurement, and cardiac function analysis.

In a 10 patient study conducted by three clinicians, the measurement of the major parameters EDV, ESV, Long. Strain Inner, Radial Strain, Total and Circumferential Strain Inner was determined to have a less than 11% coefficient of variation. Additionally, the initial contour trace lines created by the clinicians showed little differences, of which may have been attributed to ultrasound image border recognition, read out conditions, and image frame selection differences.

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-Al900, Aplio i800 Model TUS-Al800 and Aplio i700 Model TUS-AI700, V2.1 is substantially equivalent to the predicate devices. The subject devices function in a manner similar to and is intended for the same use as the predicate devices, as described in the labeling. Based upon the bench testing, 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.