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 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.

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 a 510(k) premarket notification for the Toshiba Medical Systems Corporation's Xario 200 Diagnostic Ultrasound System V5.0. This submission focuses on modifications to a previously cleared device (Xario 200, V3.0) and the introduction of new features and transducers.

The document does not describe acceptance criteria or a specific study proving the device meets those criteria in the way one might expect for a new algorithmic device with quantifiable performance metrics. Instead, it describes substantial equivalence to a predicate device and verification/validation testing against recognized standards.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for an AI component. Instead, it demonstrates performance by stating that the updates "do not raise new questions of safety and effectiveness" and that the added features perform "as expected" and are "substantially equivalent" to predicate devices.

The closest to "reported device performance" is the statement regarding the Superb Micro Vascular Imaging (SMI) feature:

Performance Characteristic	Acceptance Criteria / Predicate Equivalence	Reported Device Performance (SMI)
Image Quality (SMI)	Demonstrates imaging of low velocity flow with significant reduction in clutter noise; capable of imaging with high frame rate (based on predicate equivalence and performance described)	"SMI was capable of imaging low velocity flow with a significant reduction in clutter noise and was capable of imaging with a high frame rate."
Image Quality (Precision Plus Imaging)	Image quality improvements (based on predicate equivalence)	"Image quality improvement(s) to existing feature"
Safety and Effectiveness	Substantially equivalent to predicate device (K143027) and reference device (K151451); compliance with international standards	Device is safe and effective for its intended use; conforms to IEC60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, AIUM RTD2-2004, and ISO 10993-1.

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

The document mentions "Representative clinical images of volunteers were obtained to demonstrate that the implementation of SMI onto the subject device performed as expected." However, it does not specify the sample size (number of images or volunteers) used for this performance testing.

Data provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It only mentions "clinical images of volunteers," which suggests prospective data collection in a clinical setting, but further details are not provided.

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

The document does not specify the number of experts, their qualifications, or how they established the ground truth for any of the performance testing mentioned. This is typical for submissions focused on substantial equivalence where the primary assessment is whether the new features perform comparably to predicate devices, rather than establishing de novo clinical performance metrics against a defined ground truth.

4. Adjudication method for the test set:

The document does not describe any adjudication method used for the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this submission. The device is an ultrasound system with modified and new imaging features, not an AI-assisted diagnostic tool that directly aids human readers in interpretation or diagnosis in a quantifiable way measurable by effect size in improved reader performance. The "AI" mentioned (SMI) is an imaging enhancement technique, not an interpretive AI.

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

The performance evaluation described ("SMI was capable of imaging low velocity flow with a significant reduction in clutter noise and was capable of imaging with a high frame rate") appears to be a standalone assessment of the algorithm's technical capabilities in imaging. It describes the intrinsic performance of the SMI algorithm, without explicitly involving human interpretation performance as an outcome measure, which aligns with device modifications for image quality rather than diagnostic AI.

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

The document does not specify a formal ground truth (like pathology or outcomes data) for the evaluation of SMI. The description "SMI was capable of imaging low velocity flow with a significant reduction in clutter noise and was capable of imaging with a high frame rate" implies that the assessment was likely based on qualitative evaluation by imaging experts or quantitative technical measurements of flow and noise reduction, rather than a clinical ground truth for a specific diagnosis.

8. The sample size for the training set:

Ultrasound systems and their imaging enhancements (like SMI, ApliPure, Precision Imaging, etc.) are typically developed through engineering and signal processing, often using simulated data, phantom studies, and then clinical images for refinement and validation. The concept of a distinct "training set" in the context of machine learning, as opposed to engineering development and system optimization, is not mentioned in this document.

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

As no "training set" in the machine learning sense is described, there is no information on how ground truth for a training set was established. The development likely involved iterative engineering adjustments and testing against known benchmarks or expert qualitative assessment of image quality.

Summary of Missing Information:

The provided 510(k) summary is typical for showcasing substantial equivalence for an ultrasound imaging device with updated features rather than a novel AI-driven diagnostic algorithm. Therefore, detailed information about acceptance criteria in terms of clinical performance metrics (sensitivity, specificity), sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies for AI interpretation is largely absent. The focus is on demonstrating that the device remains safe and effective and comparable to previously cleared devices, with new features performing as expected in a technical sense.

Summary

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes coiled around it, often used as a symbol of medicine and healthcare.

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

November 1, 2016

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

Re: K162155

Trade/Device Name: Xario 200 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 13, 2016 Received: October 14, 2016

Dear Mr. Tadeo:

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

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

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

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

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

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.

Michael D.'Hara

For

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

Enclosure

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

Indications for Use

510(k) Number (if known) K162155

Device Name

Xario 200 Diaqnostic Ultrasound System V5.0

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)

ال 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."

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

System: Xario 200 TUS-X200,TUS-X200S V5.0

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(E),12(N)
Abdominal	P	P	P	P	P	2,3	P	P	P		P	4,5,6,7,8,9,11(E),12(N)
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
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(E),12(N)
Small Organ (Note 1)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Neonatal Cephalic	P	P	P	P	P	2,3	P	P	P			5,6,7,8,11(E)
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(N)
Trans-vaginal	P	P	P		P	2	P	P	P		P	4,5,6,7,8,9,12(N)
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(E),12(N)
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P	P		4, 7
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	P		4,7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P					4, 7
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
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

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

Xario 200 TUS-X200, TUS-X200S V5.0 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	P		4, 7
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	P		4, 7
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PSU-30BT

Clinical ApplicationMode 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	P		4, 7
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	P		4, 7
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 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	P		4, 7
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	P		4,7
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 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	E	E	E	E	E	3	E	E	E			7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	E	E	E	E	E	3	E	E	E			7
Small Organ (Note 1)
Neonatal Cephalic	E	E	E	E	E	3	E	E	E			7
Adult Cephalic	E	E	E	E	E	3	E	E	E			7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	E	E	E	E	E	3	E	E	E	E		4, 7
Cardiac Pediatric	E	E	E	E	E	3	E	E	E	E		4,7
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer: PVU-375BT

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				4,5,6,7,8,9,11(E),12(N
Abdominal	P	P	P	P	P	2	P	P	P				4,5,6,7,8,9,11(E),12(N
Intra-operative(Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P				4,5,6,7,8,9,11(E),12(N
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)
Intravascular
Other (Specify)
Cardiac Adult
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:__ PVU-382BT

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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PVU-674BT

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation				Combined(Specify) *	THI	AdvancedDynamicFlow	Power	CHI
B	M	PWD	CWD	ColorDoppler
Ophthalmic
Fetal	P	P	P		P	2	P	P	P	5,6,7,8,11(E),12(N)
Abdominal	P	P	P		P	2	P	P	P	5,6,7,8,11(E),12(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P	5,6,7,8,11(E),12(N)
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PVU-674MV

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation				B	M	PWD	CWD	Combined(Specify) *	THI
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer: PVU-712BT

Clinical Application	Mode of Operation								CHI2D
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow		Power
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P	5,6,7,8,11(E
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	P	P	5,6,7,8,11(E
Small Organ (Note 1)
Neonatal Cephalic	P	P	P		P	2	P	P	P	5,6,7,8,11(E
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 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			5,6,7,8,11(E)
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 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	2	P	P	P			5,6,7,8,11(E)
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 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	2	P	P	P			5,6,7,8,11(E)
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 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(N)
Trans-vaginal	P	P	P	P	P	2	P	P	P		P	5,6,7,8,12(N)
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 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	P	2	P	P	P			4,5,6,7,8,
Trans-vaginal	P	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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PVU-781VT

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)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,12(N)
Trans-vaginal	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,12(N)
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 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	E	E	E	E	2	E	E	E			4,5,6,7,8,9,12(N)
Trans-vaginal	E	E	E	E	2	E	E	E			4,5,6,7,8,9,12(N)
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

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

System: _Xario 200 TUS-X200, TUS-X200S V5.0 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(Note)
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer: PLU-704BT

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				5,6,7,8,10,11(E),12(N)
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(E),12(N)
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P				5,6,7,8,10,11(E),12(N)
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(E),12(N)
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 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	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
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			4,5,6,7,8,9,10,11(E),12(N)
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
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			4,5,6,7,8,9,10,11(E),12(N)
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer: PLU-1204BT

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	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
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			4,5,6,7,8,9,10,11(E),12(N)
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
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			4,5,6,7,8,9,10,11(E),12(N)
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 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
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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PET-512MD

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)	N	N	N	N	N	3	N					4, 7
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: 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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer: PET-805LA

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	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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PC-20M

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	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

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

System: Xario 200 TUS-X200, TUS-X200S V5.0 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

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

Image /page/29/Picture/0 description: The image contains the logo for Toshiba Medical. The logo is composed of two lines of text, with "TOSHIBA" on the top line and "MEDICAL" on the bottom line. Both lines of text are in a bold, sans-serif font and are colored red. The background of the image is white.

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
ESTABLISHMENT REGISTRATION: 3. 9614698

4. CONTACT PERSON:

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

1. Date Prepared:
  October 13, 2016

6. TRADE NAME(S):

Xario 200 Diagnostic Ultrasound System 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]

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

9. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
Xario200, V3.0 (Models:TUS-X200 and TUS-X200S)	Toshiba AmericaMedical Systems	K143027	November 20, 2014

Reference Device

Product	Marketed by	510(k) Number	Clearance Date
Aplio 500/400/300Diagnostic UltrasoundSystem, V6.0	Toshiba AmericaMedical Systems	K151451	July 9, 2015

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 V3.0 Diagnostic Ultrasound System, 510(k) cleared under K143027, marketed by Toshiba America Medical Systems. The Xario 200 Model TUS-X200 Version 5.0 and Xario200 Model TUS-X200S 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 Precision Plus Imaging, a modification to an existing feature which improves upon image quality and does not raise new questions of safety and effectiveness. Also, new features determined to be substantially equivalent to features cleared under the predicate devices referenced within this submission including SMI, Luminance and a new transducer (which is indicated for transesophageal use) are being implemented to the subject device.

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

	Xario 200Model TUS-X200,TUS-X200S v3.0	Xario 200Model TUS-X200v5.0	Xario 200Model TUS-X200Sv5.0	Comment
510(K) ControlNumber	K143027(Predicate Device)	N/A(Subject Device)	N/A(Subject Device)
Precision PlusImaging	No	Yes	No	Image qualityimprovement(s) toexisting feature
Monitor	19 inch LCD(CCFL backlight)	19 inch LCD(LED backlight)	19 inch LCD(LED backlight)	New hardware
PET-512MDTransducer	Not Available	Available	Available	New TEEtransducer,similar toPET-512MC(K103629)

Previously cleared software options being implemented to the subject device:

Application	510(k) Clearance	Comments
Superb Micro Vascular Imaging	Previously cleared underK151451	Available on Model TUS-X200 only
Luminance	Previously cleared underK151451	N/A

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

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 to demonstrate that the implementation of SMI onto the subject device performed as expected. As concluded in the study, SMI was capable of imaging low velocity flow with a significant reduction in clutter noise and was capable of imaging with a high frame rate.

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

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

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 5.0 and Xario200 Model TUS-X200S Version 5.0 do not change the intended use of the device. Based upon the 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.