The Diaqnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 And Aplio 300 Model TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using 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, transesophaqeal, musculo-skeletal (both conventional and superficial) and laparoscopic.

Device Description

The Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 and Aplio 300 Model TUS-A300 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 12 MHz.

AI/ML Overview

This document describes the 510(k) premarket notification for the Toshiba Medical Systems Corporation's Aplio 500/400/300 V5.0 Diagnostic Ultrasound System. The submission is a modification of a previously cleared device (K133761) and includes improvements to image quality, existing features (Needle Enhancement), and new features (Shear wave and Smart Navigation) along with four new transducers.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with reported device performance values. Instead, it describes "three studies" conducted to demonstrate that the new features perform as intended. The "reported device performance" is qualitative, indicating successful demonstration.

Acceptance Criterion (Implicit)	Reported Device Performance (Qualitative)
Improved Needle Visualization (Needle Enhancement Feature)	Confirmed that the subject device improves needle visualization.
Accurate Shear Wave Speed and Elasticity Measurement	Confirmed that the subject device accurately measured the shear wave speed and elasticity of known targets within an elasticity phantom.
Successful Needle Navigation (Smart Navigation Feature)	Demonstrated that the use of Smart Navigation successfully navigates needles to targets at various depths using a projected path displayed on the system.
Conformance to Safety and Quality Standards	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 60601-1-2:2007, IEC 60601-2-37 (2007), IEC 62304 (2006), AIUM RTD2-2004 Output Display and ISO 10993-1 standards. Software Documentation for a Moderate Level of Concern, per the FDA quidance 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.
Functionality Similar to Predicate Device	The Aplio 500 Model TUS-A500 Version 5.0, Aplio 400 Model TUS-A400 Version 5.0 and Aplio 300 Model TUS-A300 Version 5.0 functions in a manner similar to and is intended for the same use as the predicate devices referenced within this submission.
Image Quality Improvements (Overall)	Improvements upon image quality (qualitative statement, no specific metric provided).

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

The document states that "three studies were conducted," and the testing involved "bench testing" and "an elasticity phantom." It also mentions "targets at various depths." However, it does not specify numerical sample sizes for the test sets used in any of these studies.

The data provenance is from bench testing, implying controlled laboratory conditions rather than clinical human data. The country of origin of the data is not explicitly stated, but the submission is from "Toshiba Medical Systems Corporation, Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550". It's likely the testing occurred in Japan or the US (as part of Toshiba America Medical Systems, Inc.). The studies are prospective in nature, as they were conducted to validate the new features of the device before market clearance.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the bench testing.

For the shear wave study, "known targets within an elasticity phantom" were used. This indicates a physical phantom with pre-defined or known elastic properties, which serves as the ground truth. Therefore, expert input for ground truth establishment might have been less relevant or was built into the design of the phantom itself.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set results. The testing described appears to be objective performance evaluation based on physical measurements (e.g., accurately measuring shear wave speed) or functional confirmation (improving needle visualization, successful navigation).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in this document. The studies described are focused on the technical performance of new features rather than comparing human reader performance with and without AI assistance.

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

The performance of the "Needle Enhancement" and "Shear wave" features likely involves standalone measurements by the algorithm/system, as they are inherent imaging modes or measurement capabilities. For example, "accurately measured the shear wave speed and elasticity of known targets within an elasticity phantom" implies an algorithm-only measurement. The "Smart Navigation" feature "successfully navigates needles to targets" where the system displays a "projected path," which could be interpreted as the algorithm providing guidance that a human then follows. While not explicitly stated as "standalone evaluation," the nature of these tests suggests measuring the direct output of the device's enhanced functionalities.

7. The Type of Ground Truth Used

The types of ground truth used for the specific performance tests are:

Needle Enhancement: Implicitly, the visibility of a physical needle in an ultrasound image. The ground truth for "improved visualization" would be a qualitative assessment, possibly against a baseline or a known ideal.
Shear Wave: "Known targets within an elasticity phantom." This indicates a physical phantom with established mechanical properties (e.g., known elasticity values).
Smart Navigation: "Targets at various depths" with a "projected path displayed on the system." The ground truth here would be the physical location of the targets and the actual path the needle takes compared to the projected path.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. This is not uncommon for 510(k) submissions, especially for ultrasound systems where "AI" might refer to advanced image processing algorithms rather than deep learning models requiring large training datasets. The focus here is on the functional performance validation of hardware and software features.

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

Since no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image contains the seal of the U.S. Department of Health & Human Services. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.

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

October 28, 2014

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

Re: K141459

Trade/Device Name: Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 2, 2014 Received: October 3, 2014

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.

This determination of substantial equivalence applies to the following transducers intended for use with the Aplio 500/400/300 Diagnostic Ultrasound System, V5.0. as described in your premarket notification:

Transducer Model Number

PST-25BT	PST-30BT	PST-50BT
PST-65AT	PVT-375BT	PVT-375SC
PVT-375MV	PVT-382BT	PVT-382MV
PVT-661VT	PVT-781VT	PVT-674BT
PVT-675MV	PVT-675MVL	PVT-681MV
PVT-712BT	PVT-745BTF	PVT-745BTH
PVT-745BTV	PVT-770RT	PLT-604AT
PLT-704AT	PLT-704SBT	PLT-705BT
PLT-705BTF	PVT-705BTH	PLT-805AT

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

PLT-1005BT☐	PLT-1202S	PLT-1204BT
PLT-1204BX	PLT-1204MV	PET-508MA
PET-510MB	PET-512MC	PET-805LA
PC-20M	PC-50M

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.

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 (800) 638 2041 or (301) 796-7100 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.

{2}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Sm. 7)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known)

K141459

Device Name

Aplio 500/400/300 V5.0 Diagnostic Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

ك 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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

System: _Aplio 500, Aplio 400, Aplio 300 V5.0

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	ColorDoppler	Combined(Specify) *	THI	DynamicFlow	Power	CHI2D	4D	Other [Note]
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P	P		5,7,8,9,10,14,18
Abdominal	P	P	P	P	P	2,3	P	P	P	P		5,7,8,9,10,11,12,14,15,16,18
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P	P			4,5,7,11
Intra-operative (Neuro)
Laparoscopic	N	N	N	N	N	2	N	N	N			5,7
Pediatric	P	P	P	P	P	2,3	P	P	P	P		5,7,8,9,10,12,14,15,18
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11,14,15,17,18
Neonatal Cephalic	P	P	P	P	P	3	P	P	P
Adult Cephalic	P	P	P	P	P	3	P	P	P
Trans-rectal	P	P	P	P	P	2	P	P	P		P	4,5,7,11,12,18
Trans-vaginal	P	P	P	P	P	2	P	P	P		P	4,5,7,11,12,18
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11,14,15,17,18
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11,14,15,17,18
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P	P		4,13
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	P		4,13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P					4,13
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11,14,15,17,18
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K133761, K123992, K121422 and K103629

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD;	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

System: _ Aplio 500, Aplio 400, Aplio 300 V5.0

Transducer: _ PST-25BT

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	Other
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P	P		11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P	P
Small Organ (Specify) (1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P
Adult Cephalic	P	P	P	P	P	3	P	P	P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P	P	4,13
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	P	4,13
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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P	P			11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P	P
Small Organ (Specify) (1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P
Adult Cephalic	P	P	P	P	P	3	P	P	P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P	P		4,13
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	P		4,13
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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P	P			11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P	P
Small Organ (Specify) (1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P
Adult Cephalic	P	P	P	P	P	3	P	P	P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P	P		4,13
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	P		4,13
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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	3	P	P	P			11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	3	P	P	P
Small Organ (Specify) (1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P
Adult Cephalic	P	P	P	P	P	3	P	P	P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P	P		4,13
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	P		4,13
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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

System: _Aplio 500, Aplio 400, Aplio 300 V5.0

Transducer:___PVT-375BT

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P			5,7
Abdominal	P	P	P		P	2	P	P	P			5,7,11,12,15,16,18
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P			5, 7,12,15,18
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

System: _Aplio 500, Aplio 400, Aplio 300 V 5.0

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal	N	N	N	N	N	2	N	N	N			5,7
Abdominal	N	N	N	N	N	2	N	N	N			5,7,11,12,15,16,18
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	2	N	N	N			5,7,12,15,18
Small Organ (Specify) (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 transducer: N/A

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

System: _ Aplio 500, Aplio 400, Aplio 300 V5.0

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P		P	5,7,8,9,10
Abdominal	P	P	P		P	2	P	P	P		P	5,7,8,9,10
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P		P	5,7,8,9,10
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

System: _Aplio 500, Aplio 400, Aplio 300 V5.0

Transducer:___PVT-382BT

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P				5, 7,18
Abdominal	P	P	P		P	2	P	P	P				5, 7,12,18
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P				5, 7,12,18
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	4D	Other
Ophthalmic
Fetal	P	P	P	P	2	P	P	P	P	5,7,9
Abdominal	P	P	P	P	2	P	P	P	P	5,7,9
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P	P	5,7,9
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

System: _ Aplio 500, Aplio 400, Aplio 300 V5.0 Transducer:____PVT-661VT

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	2	P	P	P			4,5,7,11
Trans-vaginal	P	P	P	P	P	2	P	P	P			4,5,7,11
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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

System: _ Aplio 500, Aplio 400, Aplio 300 V5.0 Transducer:____PVT-781VT

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	2	P	P	P			4,5,7,11,12,15,18
Trans-vaginal	P	P	P	P	P	2	P	P	P			4,5,7,11,12,15,18
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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P			5,7,14,15
Abdominal	P	P	P	P	P	2	P	P	P			5,7,14,15
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P			5,7,14,15
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	4D	Other[Note]
Ophthalmic
Fetal	P	P	P	P	2	P	P	P	P	5,7,8,9,10
Abdominal	P	P	P	P	2	P	P	P	P	5,7,8,9,10
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P	P	5,7,8,9,10
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

System: _Aplio 500, Aplio 400, Aplio 300 V5.0

Transducer: PVT-675MVL

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	4D	Other[Note]
Ophthalmic
Fetal	N	N	N	N	N	2	N	N	N	N	5,7,8,9,10
Abdominal	N	N	N	N	N	2	N	N	N	N	5,7,8,9,10
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	2	N	N	N	N	5,7,8,9,10
Small Organ (Specify) (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 transducer: N/A

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 TDI
------------

Note 5 ApliPure
-----------------

Note 6 MicroPure
------------------

Note 7 Precision Imaging
--------------------------

Note 8 STIC
-------------

Note 9 3D Color (Volume Color)
--------------------------------

Note 10 STIC Color
--------------------

Note 11 Elastography
----------------------

Note 12 Fusion
----------------

Note 13 2D WMT
----------------

Note 14 Boost
---------------

Note 15 SMI
-------------

Note 16 Shear wave
--------------------

Note 17 BEAM
--------------

Note 18 Smart Navigation
--------------------------

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

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	CWD	P	2	P	P	P	CHI	P	4,5,7,9,11
Trans-vaginal	P	P	P	CWD	P	2	P	P	P	CHI	P	4,5,7,9,11
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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P			5,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P			5,7
Small Organ (Specify) (1)
Neonatal Cephalic	P	P	P		P	2	P	P	P			5,7
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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P			5,7
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,7
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	b	P	P			5,7
Intra-operative (Abdominal)	P	b	P		P	2	b	P	P			5,7
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

System: _Aplio 500, Aplio 400, Aplio 300 V5.0 Transducer:____PVT-745BTV

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P			5,7
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,7
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)米		THI DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	b	P	P		P	2	b	P	P			4,5,7,11
Trans-vaginal	b	P	P		P	2	b	P	P			4,5,7,11
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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

System: _Aplio 500, Aplio 400, Aplio 300 V5.0 Transducer:___PLT-604AT

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P	P	P	2	P	P	P				5,7,17
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				5,7,17
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P				5,7,17
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				5,7,17
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P	P	P	2	P	P	P			5,7,17
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			5,7,17
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P			5,7
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			5,7,17
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P	P	P	2	P	P	P			5,7,14,15,17
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			5,7,14,15,17
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P			5,7,14,15,17
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			5,7,14,15,17
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power2D	CHI2D	4D	Other [Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	N	N	N	N	N	2	N	N	N			5,7,15,17
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			5,7,15,17
Musculo-skeletal (Superficial)	N	N	N	N	N	2	N	N	N			5,7,15,17
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			5,7,15,17
Other (Specify)

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

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P			5,7
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P	P			5,7
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P			5,7
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,7
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P	P	P	2	P	P	P				5,6,7,11,17
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				5,6,7,11,17
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P				5,6,7,11,17
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				5,6,7,11,17
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

System: _Aplio 500, Aplio 400, Aplio 300 V5.0

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	ColorDoppler	Combined(Specify)*	THI	Dynamic Flow	Power	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P	P	2	P	P	P	5,6,7,11,12,14,15,17,18
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	5,6,7,11,12,14,15,17,18
Musculo-skeletal (Superficial)	P	P	P	P	2	P	P	P	5,6,7,11,12,14,15,17,18
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	5,6,7,11,12,14,15,17,18
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)	P	P	P		P	2	P		P				4,5,11
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P		P	2	P		P				4,5,11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P		P	2	P		P				4,5,11
Musculo-skeletal (Superficial)	P	P	P		P	2	P		P				4,5,11
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				4,5,11
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P		P	2	P	P	P			4,5,6,7,11,15,17
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			4,5,6,7,11,15,17
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			4,5,6,7,11,15,17
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			4,5,6,7,11,15,17
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P		P	2	P	P	P				5,7,15,17
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				5,7,15,17
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P				5,7,15,17
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				5,7,15,17
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

System: _Aplio 500, Aplio 400, Aplio 300 V5.0 Transducer:___PLT-1204MV

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P	P	P	2	P	P	P	P	P	5,7,8,9,10
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	5,7,8,9,10
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P	P	P	5,7,8,9,10
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	5,7,8,9,10
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

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

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (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					4,13
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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

{38}------------------------------------------------

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation			B	M	PWD	CWD	Power
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (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	4,13
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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

{39}------------------------------------------------

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power2D	CHI4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (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				4,13
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 transducer: K103629

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

{40}------------------------------------------------

System: _Aplio 500, Aplio 400, Aplio 300 V5.0 Transducer:___PET-805LA

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	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic	N	N	N	N	N	2	N	N	N			5,7
Pediatric
Small Organ (Specify) (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 transducer: N/A

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

{41}------------------------------------------------

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation			B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

{42}------------------------------------------------

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (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 transducer: K133761

Note 1 Small organ includes thyroid, breast and testicle	Note 7 Precision Imaging	Note 13 2D WMT
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD	Note 8 STIC	Note 14 Boost
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD	Note 9 3D Color (Volume Color)	Note 15 SMI
Note 4 TDI	Note 10 STIC Color	Note 16 Shear wave
Note 5 ApliPure	Note 11 Elastography	Note 17 BEAM
Note 6 MicroPure	Note 12 Fusion	Note 18 Smart Navigation

{43}------------------------------------------------

Image /page/43/Picture/0 description: The image shows the Toshiba logo. The word "TOSHIBA" is written in large, red, bold letters. Below the company name is the slogan "Leading Innovation" in black, followed by three gray arrows pointing to the right.

TOSHIBA AMERICA MEDICAL SYSTEMS, INC

2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000

510(k) SUMMARY

SUBMITTER'S NAME: 1.

Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550

1. OFFICIAL CORRESPONDENT Akinori Hatanaka
1. ESTABLISHMENT REGISTRATION: 9614698

CONTACT PERSON: 4.

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

5. Date Prepared:

May 27, 2014

6. TRADE NAME(S):

Diagnostic Ultrasound System Aplio 500 Model TUS-A500 V5.0 Aplio 400 Model TUS-A400 V5.0 Aplio 300 Model TUS-A300 V5.0

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]

Page 1 of 3

{44}------------------------------------------------

9. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
Aplio 500/400/300 DiagnosticUltrasound System V4.0	Toshiba AmericaMedical Systems	K133761	April 22, 2014
AIXPLORER UltrasoundSystem	SuperSonic Imagine,S.A.	K112255	August 28, 2012
GE Logiq E9 BT2010Diagnostic Ultrasound System	GE Healthcare	K092271	November 17, 2009
Electromagnetic TrackingSystem	CIVCO MedicalInstruments Co., Inc.	K092619	November 13, 2009
MicroMaxx High ResolutionUltrasound System (C3 Series)	SonoSite, Inc.	K053069	February 24, 2006

10. REASON FOR SUBMISSION:

Modification of a cleared device

11. DEVICE DESCRIPTION:

12. INDICATIONS FOR USE:

The Diagnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 And Aplio 300 Model TUS-A300 is 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 500/400/300 V4.0 Diagnostic Ultrasound Svstem. 510(k) cleared under K133761. marketed by Toshiba America Medical Systems. The Aplio 500 Model TUS-A500 Version 5.0. Aplio 400 Model TUS-A400 Version 5.0 and Aplio 300 Model TUS-A300 Version 5.0 functions in a manner similar to and is intended for the same use as the predicate devices referenced within this submission. The subject device includes modifications to the cleared device which improve upon image quality and existing features (Needle Enhancement). Also, new features determined to be substantially equivalent to features cleared under the predicate devices referenced within this submission including Shear wave and Smart Navigation and four new transducers (one of

{45}------------------------------------------------

which is indicated for laparoscopic use) are being added to the subject device. A comparison table is included in this submission which details the similarities and differences between the predicate devices and the subject 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 60601-1-2:2007, IEC 60601-2-37 (2007), IEC 62304 (2006), AIUM RTD2-2004 Output Display and ISO 10993-1 standards.

15. TESTING

Risk Analysis, Verification/Validation testing conducted through bench testing.

Performance Testing - Bench

Three studies were conducted to demonstrate that the new features being implemented to the subject device performed as intended. One study compared an existing imaging mode with the needle enhancement feature and confirmed that the subject device improves needle visualization. Another study confirmed that the subject device accurately measured the shear wave speed and elasticity of known targets within an elasticity phantom while a third study demonstrated that the use of Smart Navigation successfully navigates needles to targets at various depths using a projected path displayed on the system.

Software Documentation for a Moderate Level of Concern, per the FDA quidance 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 the modified system was conducted in accordance with the applicable standards published by the International Clectrotechnical Commission (IEC) for Medical Devices.

16. CONCLUSION

The modifications incorporated into the Aplio 500 Model TUS-A500 Version 5.0. Aplio 400 Model TUS-A400 Version 5.0 and Aplio 300 Model TUS-A300 Version 5.0 do not change the intended use of the device. Based upon bench testing, 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.