The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S 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), laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

Device Description

The Xario200 Model TUS-X200 and Model TUS-X200S 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

The provided text describes modifications to an ultrasound system, the Xario 200 Diagnostic Ultrasound System V6.0, and states that these modifications do not change the intended use of the device. The modifications primarily involve the addition of new transducers and implementation of previously cleared software options. Therefore, the acceptance criteria and study information provided are primarily focused on demonstrating that the new transducers and software features perform as intended and are substantially equivalent to previously cleared devices or features.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for the device's overall performance. Instead, it refers to the device performing "as intended" for the new features based on comparisons to predicate software/devices. The criteria for demonstrating safety and effectiveness likely included successfully fulfilling the intended use, maintaining image quality, and adhering to applicable medical device standards.

Acceptance Criteria (Inferred)	Reported Device Performance
New transducers (PLU-1202BT and others for specific applications) function as intended.	The various tables for each transducer (PSU-25BT, PSU-30BT, PSU-50BT, PSU-70BT, PVU-375BT, PVU-382BT, PVU-674BT, PVU-674MV, PVU-712BT, PVU-745BTF, PVU-745BTH, PVU-745BTV, PVU-681MVL, PVU-770ST, PVU-781VT, PVU-781VTE, PVL-715RS, PLU-704BT, PLU-1005BT, PLU-1202BT, PLU-1204BT, PET-512MC, PET-512MD, PET-805LA, PC-20M, PC-50M) are listed with their supported clinical applications and modes of operation, indicating suitability for their intended uses. For new indications, they are marked as 'N'.
2D Wall Motion Tracking (2D WMT) performs as intended in comparison to predicate software.	Clinical images of volunteers were obtained, and it was concluded that 2D WMT implemented on the subject device performs as intended in comparison to the predicate software. Specifically, it enables cardiac wall trace, local wall motion tracking, wall motion information analysis and display, cardiac volume measurement, and cardiac function analysis.
Shear Wave feature performs as expected including measurement quantification accuracy and precision.	Bench testing using an elasticity phantom demonstrated that the implementation of Shear Wave onto the subject device performed as intended, including measurement quantification accuracy and precision.
The device maintains conformance with applicable standards.	The device is designed and manufactured under the Quality System Regulations (21 CFR § 820 and ISO 13485 Standards). Conforms with applicable parts of IEC60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, AIUM RTD2-2004 Output Display, and ISO 10993-1 standards. Software Documentation for a Moderate Level of Concern was included as per FDA guidance.
Software validation is successful.	Successful completion of software validation is reported.

Study Information

Sample size used for the test set and the data provenance:
- 2D Wall Motion Tracking: "Representative clinical images of volunteers were obtained." The exact sample size is not specified. The data provenance is implied to be clinical, but the country of origin is not detailed. Given the company is "Toshiba Medical Systems Corporation" in Japan and "Toshiba America Medical Systems, Inc" in the USA, it could be from either or both.
- Shear Wave: "Bench testing was done using an elasticity phantom." This indicates a non-human, controlled setting. No specific sample size (e.g., number of phantoms or measurements) is provided.
- Transducers: No specific test set size or data provenance is mentioned for the general performance of the new transducers beyond their listed clinical applications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. The document states "it was concluded" for 2D WMT and "As concluded in the study" for Shear Wave, implying expert assessment, but details about the number or qualifications of these experts are missing.
Adjudication method for the test set: Not specified.
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: Not explicitly stated. The document mentions 2D WMT "compared to predicate software", but this does not describe a comparative effectiveness study involving human readers with and without AI assistance for improved performance. The device itself is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool in the sense of a standalone AI algorithm for interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes bench testing for Shear Wave and clinical image evaluation for 2D WMT. While these tests evaluate the algorithm/feature's performance and output, it's not clear if a standalone algorithm-only performance assessment without any human review or interpretation of the output was conducted or reported. However, for an ultrasound system, the output (images, measurements) is inherently for human interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- 2D Wall Motion Tracking: The phrase "Representative clinical images of volunteers were obtained" and "performs as intended" suggests a comparison against expected normal cardiac function and/or comparisons with the predicate device's output, likely adjudicated by clinical experts.
- Shear Wave: "Bench testing using an elasticity phantom" implies a known, controlled physical property as ground truth for measurement accuracy and precision.
The sample size for the training set: Not applicable and not mentioned. This document pertains to a diagnostic ultrasound system and its software features, not an AI/ML model that typically requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for an AI/ML model.

Summary

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December 12, 2017

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

Re: K172276

Trade/Device Name: Xario 200 Diagnostic Ultrasound System V6.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 26, 2017 Received: July 28, 2017

Dear Orlando Tadeo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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Page 2 - Orlando Tadeo

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert A. 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)

K172276

Device Name

Xario 200 Diaqnostic Ultrasound System V6.0

Indications for Use (Describe)

The Diaqnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S are 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), laparoscopic, pediatric, small orqans, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

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

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System: Xario 200 TUS-X200,TUS-X200S V6.0

Transducer:

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI>	4D	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P		P	4,5,6,7,8,9,11,12
Abdominal	P	P	P	P	P	2,3	P	P	P		P	4,5,6,7,8,9,11,12,14
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic	P	P	P		P	2	P	P	P			5,7
Pediatric	P	P	P	P	P	2,3	P	P	P		P	4,5,6,7,8,9,11,12
Small Organ (Note 1)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11,12
Neonatal Cephalic	P	P	P	P	P	2,3	P	P	P			5,6,7,8,11
Adult Cephalic	P	P	P	P	P	3	P	P	P			7
Trans-rectal	P	P	P		P	2	P	P	P		P	4,5,6,7,8,9,12
Trans-vaginal	P	P	P		P	2	P	P	P		P	4,5,6,7,8,9,12
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11,12
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11,12
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P			4, 7, 13(N)
Cardiac Pediatric	P	P	P	P	P	3	P	P	P			4, 7, 13(N)
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P					4, 7, 13(N)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11,12
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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Xario 200 TUS-X200, TUS-X200S V6.0 System: _ Transducer: PSU-25BT

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	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			7
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P			7
Adult Cephalic	P	P	P	P	P	3	P	P	P			7
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			4, 7, 13(N)
Cardiac Pediatric	P	P	P	P	P	3	P	P	P			4, 7, 13(N)
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking

Note 14 Shear Wave

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System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PSU-30BT

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	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			7
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P			7
Adult Cephalic	P	P	P	P	P	3	P	P	P			7
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			4, 7, 13(N
Cardiac Pediatric	P	P	P	P	P	3	P	P	P			4, 7, 13(N
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PSU-50BT

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI>	4D	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			7
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P			7
Adult Cephalic	P	P	P	P	P	3	P	P	P			7
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			4, 7, 13(N)
Cardiac Pediatric	P	P	P	P	P	3	P	P	P			4, 7, 13(N)
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PSU-70BT

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	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			7
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	3	P	P	P			7
Adult Cephalic	P	P	P	P	P	3	P	P	P			7
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			4, 7, 13(N)
Cardiac Pediatric	P	P	P	P	P	3	P	P	P			4, 7, 13(N)
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: __ PVU-375BT

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,11,12
Abdominal	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,11,12,1
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,11,12
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus

Note 7 Precision Imaging

Note 8 Differential THI Note 9 Elastography

Note 9 Elastography
No. 10 BEAM

Note 10 BEAM

Note 11 Smart 3D Note 12 SMI

Note 13 2D Wall Motion Tracking

Note 14 Shear Wave

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System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: __ PVU-382BT

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI>	4D	Other[Note]
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Abdominal	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P			5,6,7,8,11
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-674BT

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P			5,6,7,8,11,1
Abdominal	P	P	P		P	2	P	P	P			5,6,7,8,11,1
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P			5,6,7,8,11,1
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PVU-674MV

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	4D	Other[Note]
Ophthalmic
Fetal	P	P	P	P	2	P	P	P	P	5,6,7,8
Abdominal	P	P	P	P	2	P	P	P	P	5,6,7,8
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P	P	5,6,7,8
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-712BT

Clinical Application	Mode of Operation									Other[Note]
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P	5,6,7,8,1
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P	5,6,7,8,1
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	2	P	P	P	5,6,7,8,1
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-745BTF

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P			5,6,7,8,1
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,6,7,8,1
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			5,6,7,8,1
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-745BTH

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P	P			5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P			5,6,7,8,11
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-745BTV

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI>	4D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	P	P			5,6,7,8,1
Intra-operative (Abdominal)	P	P	P	P	P	2	P	P	P			5,6,7,8,1
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P			5,6,7,8,1
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: _Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-681MVL

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
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	5,6,7,8,12
Trans-vaginal	P	P	P	P	P	2	P	P	P		P	5,6,7,8,12
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-770ST

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
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			4,5,6,7,8,
Trans-vaginal	P	P	P		P	2	P	P	P			4,5,6,7,8,
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: _Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-781VT

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI>	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
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			4,5,6,7,8,9,1
Trans-vaginal	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,1
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-781VTE

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
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			4,5,6,7,8,9,10
Trans-vaginal	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVL-715RS

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
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			5,6,7,8,12
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PLU-704BT

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamic Flow	Power	CHI>	4D	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			5,6,7,8,10,11,1
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			5,6,7,8,10,11,1
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P			5,6,7,8,10,11,1
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			5,6,7,8,10,11,1
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus

Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PLU-1005BT

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	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			4,5,6,7,8,9,10,11,
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			4,5,6,7,8,9,10,11,
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11,
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			4,5,6,7,8,9,10,11,
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus

Note 7 Precision Imaging

Note 8 Differential THI
Note 9 Elastography

Note 10 BEAM

Note 11 Smart 3D

Note 12 SMI

Note 13 2D Wall Motion Tracking

Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PLU-1202BT

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI	4D	Other [Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)	N	N	N	N	N	2	N	N	N			5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	N	N	N	N	N	2	N	N	N			4,5,6,7,8,9,11,12
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			4,5,6,7,8,9,11,12
Musculo-skeletal (Superficial)	N	N	N	N	N	2	N	N	N			4,5,6,7,8,9,11,12
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			4,5,6,7,8,9,11,12
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PLU-1204BT

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation										Other[Note]
	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI>	4D
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11,1
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			4,5,6,7,8,9,10,11,1
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11,1
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			4,5,6,7,8,9,10,11,1
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking

Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PET-512MC

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	AdvancedDynamicFlow	Power	CHI	4D	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					4, 7, 13(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: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PET-512MD

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	AdvancedDynamicFlow	Power	CHI	4D	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					4, 7, 13(Note)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PET-805LA

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	DynamicFlow	Power	CHI	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic	P	P	P		P	2	P	P	P				5,7
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)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PC-20M

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	AdvancedDynamicFlow	Power	CHI	4D	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				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: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking Note 14 Shear Wave

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

System: Xario 200 TUS-X200, TUS-X200S V6.0 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	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI>	4D	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			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: K143027

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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

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

510(k) SUMMARY

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

July 25, 2017

6. TRADE NAME(S):

Xario 200 Diagnostic Ultrasound System V6.0

7. COMMON NAME:

System, Diagnostic Ultrasound

8. DEVICE CLASSIFICATION:

Class II

Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [per 21 CFR 892.1550] Ultrasonic Pulsed Echo Imaging System – Product Code: 90-IYO [per 21 CFR 892.1560] Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [per 21 CFR 892.1570]

TOSHIBA AMERICA MEDICAL SYSTEMS

Image /page/30/Picture/18 description: The image shows the logo for Canon Group. The word "Canon" is written in red, with a stylized "o" that has a white diagonal line through it. Below the word "Canon" is the text "CANON GROUP" in black, block letters. The logo is simple and recognizable.

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

9. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
Xario200, V5.0 (Models:TUS-X200 and TUS-X200S)	Toshiba AmericaMedical Systems	K162155	October 14, 2016

10. REASON FOR SUBMISSION:

Modification of a cleared device

11. DEVICE DESCRIPTION:

12. INDICATIONS FOR USE:

The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S 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), laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric, transesoph(cardiac) and peripheral vessel.

13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Xario200 V5.0 Diagnostic Ultrasound System, 510(k) cleared under K162155, marketed by Toshiba America Medical Systems. The Xario 200 Model TUS-X200 Version 6.0 and Xario200 Model TUS-X200S Version 6.0 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 improves upon existing features. Also, new features determined to be substantially equivalent to features cleared under the predicate devices referenced within this submission. A comparison table is included in this submission which details the similarities and differences between the predicate devices and the subject device.

	Xario 200Model TUS-X200,TUS-X200S v5.0	Xario 200Model TUS-X200 andTUS-X200S v6.0	Comment
510(K) ControlNumber	K162155(Predicate Device)	N/A(Subject Device)
Uninterruptible PowerSupply (UPS)	Not Available	Available	New UPS
PLU-1202BT	Not Available	Available	New transducer

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

Previously cleared software options being implemented to the subject device:

Application	510(k) Clearance	Comments
Tissue Specific Optimization	Previously cleared under K151451	No change from previous clearance
2D Wall Motion Tracking	Previously cleared under K151451	No change from previous clearance
Shear wave	Previously cleared under K151451	No change from previous clearance. Available on TUS-X200 only
SMIColor	c-SMI previously cleared under K162155	SMI available on TUS-X200 only
SMIMonochrome	m-SMI previously cleared under K151451	Addition of monochrome mapping

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, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, AIUM RTD2-2004 Output Display and ISO 10993-1 standards.

15. TESTING

Design Control Activities including risk management following ISO14971, verification/validation testing and Acoustic Output testing (UD3, 2004) were conducted and included in this submission.

Performance Testing - Clinical Images

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

Performance Testing - Bench

Bench testing was done using an elasticity phantom to demonstrate that the implementation of Shear Wave onto the subject device performed as expected including measurement quantification accuracy and precision. As concluded in the study, Shear Wave performed as intended.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in

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

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 Electrotechnical Commission (IEC) for Medical Devices.

16. CONCLUSION

The modifications incorporated into the Xario 200 Model TUS-X200 Version 6.0 and Xario200 Model TUS-X200S Version 6.0 do not change the intended use of the device. Based upon 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.