Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of performance studies focuses on standard image processing and measurement techniques without mentioning AI/ML.

Therapeutic

No
Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis," indicating it is a diagnostic tool, not a therapeutic one.

Diagnostic

Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "to provide image information for diagnosis" and the "Device Description" section identifies it as a "mobile diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mobile diagnostic ultrasound system" and mentions employing "a wide array of probes," which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
Device Function: The description clearly states that the device is a "Diagnostic Ultrasound System" used for the "visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis". This involves using ultrasound waves to create images of internal body structures in vivo (within the living body).
Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is based on real-time imaging of the body itself.

Therefore, while it is a diagnostic device, it falls under the category of medical imaging equipment used in vivo, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs (thyroid, breast and testicle), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K162155

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K151451, K143027

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on the second line.

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);

1

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

2

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

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 V6.0

Transducer:

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	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

4

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	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

5

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	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

6

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	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

7

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	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

8

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

| Clinical Application
Specific

(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	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

9

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	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 Application
Specific

(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	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 Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 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 | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | 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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	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 Application
Specific

(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
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	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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
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	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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
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	4,5,6,7,8,9,1
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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
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	4,5,6,7,8,9,10
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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
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	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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic 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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
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	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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	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 Application
Specific
(Tracks 3) | Mode of Operation | | | | | | | | | | Other
[Note] | |
|------------------------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|------|-----------------|---------------------|
| | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | 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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
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
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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
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
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	Color
Doppler	Combined
(Specify) *	THI	Dynamic
Flow	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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
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
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	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
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
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
Xario200, V5.0 (Models:
TUS-X200 and TUS-X200S)	Toshiba America
Medical Systems	K162155	October 14, 2016

10. REASON FOR SUBMISSION:

Modification of a cleared device

11. 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.

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 200
Model TUS-X200,
TUS-X200S v5.0 | Xario 200
Model TUS-X200 and
TUS-X200S v6.0 | Comment |
|---------------------------------------|------------------------------------------------|---------------------------------------------------|----------------|
| 510(K) Control
Number | K162155
(Predicate Device) | N/A
(Subject Device) | |
| Uninterruptible Power
Supply (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
SMI
Color	c-SMI previously cleared under K162155	SMI available on TUS-X200 only
SMI
Monochrome	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.