The Diaqnostic Ultrasound System Xario 100 Model TUS-X100 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), laparoscopic, pediatric, small orqans, neonatal cephalic, adult cephalic, trans-rectal, trans-vaqinal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

Device Description

The Xario 100 Model TUS-X100 is a mobile diagnostic ultrasound system. This system is a Track 3 device that employs 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 is a 510(k) summary for the Toshiba Medical Systems Corporation's Xario 100 Diagnostic Ultrasound System, V5.0. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (Xario 100, V3.0, K143046) and does not contain detailed information about specific acceptance criteria or a clinical study proving device performance against those criteria.

The submission outlines modifications to an already cleared device, including software updates (Luminance), a new transducer (for transesophageal use, PET-512MD), and a new feature (Touch Command Screen). The document concludes that these modifications do not change the intended use and that the device is safe and effective based on internal design control activities, risk management, verification/validation testing, and conformance to international standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details of a specific study proving device performance, as this information is not present in the provided text. The document refers to "Design Control Activities including risk management," "verification/validation testing," and "Acoustic Output testing," but does not detail the specific criteria or results of these tests in a way that allows for a direct answer to the request.

However, I can extract information related to other aspects of your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Not explicitly provided in the document. The document states that "Design Control Activities including risk management... verification/validation testing and Acoustic Output testing (UD3, 2004) were conducted and included in this submission," and that the 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." However, the specific acceptance criteria and detailed performance metrics from these tests are not included here.

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

Not specified in the provided text. The document refers to "verification/validation testing" but does not detail the sample size or the nature (e.g., country of origin, retrospective/prospective) of the data used for testing.

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

Not specified in the provided text. The document refers to validation testing but does not mention the use of experts for ground truth establishment.

4. Adjudication Method for the Test Set:

Not specified in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with AI vs. Without AI Assistance:

Not applicable. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically involve a MRMC study for human reader improvement with AI. The document describes software modifications (Luminance) and new hardware (transducer, Touch Command Screen) for the ultrasound system itself.

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

Not applicable, as this is a diagnostic ultrasound system.

7. The Type of Ground Truth Used:

Not explicitly stated for any specific test. The document refers to conformance with various IEC and ISO standards and AIUM guidelines, implying that performance was evaluated against established technical and safety requirements, rather than clinical ground truth like pathology or outcomes data in the context of an AI algorithm.

8. The Sample Size for the Training Set:

Not applicable. This document describes a traditional medical device (ultrasound system) clearance, not an AI/ML-based device that would typically have a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing to the right, stacked on top of each other.

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

September 30, 2016

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

Re: K162187

Trade/Device Name: Xario 100 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: August 2, 2016 Received: August 4, 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

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Indications for Use

510(k) Number (if known) K162187

Device Name

Xario 100 Diaqnostic Ultrasound System, V5.0

Indications for Use (Describe)

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)

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

System: Xario 100 TUS-X100, V5.0

Transducer:

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	4D	Other[Note]
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P	P	4,5,6,7,8,11(E)
Abdominal	P	P	P	P	P	2,3	P	P	P	P	4,5,6,7,8,11(E)
Intra-operative(Abdominal)	P	P	P		P	2	P	P	P		5,6,7,8,11(E)
Intra-operative (Neuro)
Laparoscopic	P	P	P		P	2	P	P	P		5,7
Pediatric	P	P	P	P	P	2,3	P	P	P	P	4,5,6,7,8,11(E)
Small Organ (Note 1)	P	P	P		P	2	P	P	P		4,5,6,7,8,9,10,11(E)
Neonatal Cephalic	P	P	P	P	P	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	4,5,6,7,8,11(E)
Trans-vaginal	P	P	P		P	2	P	P	P	P	4,5,6,7,8,11(E)
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)
Musculo-skeletal(Superficial)	P	P	P		P	2	P	P	P		4,5,6,7,8,9,10,11(E)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P		4,7
Cardiac Pediatric	P	P	P	P	P	3	P	P	P		4,7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P				4,7
Intra-cardiac
Other (Specify)
Peripheral vascular	P	P	P	P	P	2	P	P	P		4,5,6,7,8,9,10,11(E)
Other (Specify)

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

Previous 510(k) of the transducers: K143046

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 6 ApliPure Plus

Note 7 Precision Imaging

Note 8 Differential THI

Note 9 Elastography

Note 10 BEAM

Note 11 Smart 3D

Note 5 ApliPure

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

Xario 100 TUS-X100, V5.0 System: _ Transducer:_ PSU-25BT

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	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	N			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)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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/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

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

Xario 100 TUS-X100, V5.0 System: _ Transducer:_ PSU-30BT

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	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
Cardiac Pediatric	P	P	P	P	P	3	P	P	P			4,7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vascular
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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/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

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

System: Xario 100 TUS-X100, V5.0 Transducer: __ PSU-50BT

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	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)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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/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

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

System: Xario 100 TUS-X100, V5.0 Transducer: __ PSU-70BT

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation										Other[Note]
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	CHI	4D
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)

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/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

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

System: _Xario 100 TUS-X100,V5.0 Transducer:

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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

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

System: Xario 100 TUS-X100, V5.0 Transducer: _ PVU-382BT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	CHI	4D	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)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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/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

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

System: _Xario 100 TUS-X100, V5.0 Transducer: __ PVU-674BT

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	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)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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

System: Xario 100 TUS-X100 V5.0 Transducer: __ PVU-674MV

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	ColorDoppler	Combined*(Specify)	THI	AdvancedDynamicFlow	Power	4D	Other[Note]
Ophthalmic
Fetal	P	P	P	P	2	P	P	P	P	5,6,7,8
Abdominal	P	P	P	P	2	P	P	P	P	5,6,7,8
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	P	P	P	5,6,7,8
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vascular
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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/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

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

System: Xario 100 TUS-X100, V5.0 Transducer: PVU-712BT

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	CHI2D	4D	Other[Note]
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)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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

Other [Note]

5,6,7,8,11(E) 5,6,7,8,11(E)

5,6,7,8,11(E)

System: Xario 100 TUS-X100, V5.0 PVU-745BTF Transducer:_

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)

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

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: K143046

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

System: _Xario 100 TUS-X100, V5.0 Transducer: __ PVU-745BTH

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(
Intra-operative (Abdominal)	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	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: K143046

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

System: Xario 100 TUS-X100, V5.0 Transducer:____PVU-745BTV

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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

System: _Xario 100 TUS-X100, V5.0 Transducer: PVU-681MVL

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	P	P	P	P	P	2	P	P	P		P	5,6,7,8
Trans-vaginal	P	P	P	P	P	2	P	P	P		P	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)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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/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

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

System: Xario 100 TUS-X100, V5.0 Transducer: __ PVU-770ST

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	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)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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/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

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

System: Xario 100 TUS-X100, V5.0 Transducer: __ PVU-781VT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	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 vascular
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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/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

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

System: Xario 100 TUS-X100, V5.0 Transducer: __ PVU-781VTE

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	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	E	2	E	E	E				4,5,6,7,8
Trans-vaginal	E	E	E	E	E	2	E	E	E				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 vascular
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/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

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

System: Xario 100 TUS-X100, V5.0 Transducer:___PVL-715RS

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	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	2	P	P	P			5,6,7,8
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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/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

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

System: Xario 100 TUS-X100, 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	2	P	P	P				5,6,7,8,10,11(E)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P		P	2	P	P	P				5,6,7,8,10,11(E)
Musculo-skeletal(Superficial)	P	P	P		P	2	P	P	P				5,6,7,8,10,11(E)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vascular	P	P	P		P	2	P	P	P				5,6,7,8,10,11(E)
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: K143046

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

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

System: Xario 100 TUS-X100, V5.0 Transducer:__ PLU-1005BT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E)
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)
Musculo-skeletal(Superficial)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vascular	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E)
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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/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

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

System: Xario 100 TUS-X100, 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
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
Musculo-skeletal(Superficial)	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	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: K143046

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

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

System: Xario 100 TUS-X100, 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: K143046

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/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

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

System: Xario 100 TUS-X100, V5.0 Transducer: PET-512MD

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	N	N	N	N	N	3	N					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: 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/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

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

System: _Xario 100 TUS-X100, V5.0 Transducer: PET-805LA

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

Clinical Application				Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic	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)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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

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

System: Xario 100 TUS-X100, V5.0 Transducer: PC-20M

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143046

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/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

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

System: Xario 100 TUS-X100, 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: K143046

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/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

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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: September 27, 2016

6. TRADE NAME(S):

Xario 100 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]

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9. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
Xario100, V3.0(Models: TUS-X100, TUS-X100S)	Toshiba AmericaMedical Systems	K143046	November 19, 2014

10. REASON FOR SUBMISSION:

Modification of a cleared device

11. DEVICE DESCRIPTION:

12. INDICATIONS FOR USE:

The Diagnostic Ultrasound System Xario 100 Model TUS-X100 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), 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.

13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Xario 100 V3.0 Diagnostic Ultrasound System, 510(k) cleared under K143046, marketed by Toshiba America Medical Systems. The Xario 100 Model TUS-X100 Version 5.0 functions in a manner similar to and is intended for the same use as the predicate device referenced within this submission. The subject device includes modifications to the cleared device which improves upon existing features including the 4D image visualization (Luminance). Also, new features determined to be substantially equivalent to features cleared under the predicate devices referenced within this submission including a new transducer (which is indicated for transesophageal use) and the Touch Command Screen are being added to the subject device.

	Xario 100, V3.0Model TUS-X100	Xario 100 V5.0Model TUS-X100	Comments
510(K) Control Number	K143046(Predicate Device)	N/A(Subject)
PET-512MD Transducer	Not Available	Available	New TEE Transducer
Touch Command Screen	Not Available	Available	New feature

Previously cleared software options being implemented to the subject device:

Application	510(k) Clearance	Comments
Luminance	Previously cleared under K151451	No change to basic function

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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 the ISO14971, verification/validation testing and Acoustic Output testing (UD3, 2004) were conducted and included in this submission.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

Additionally, testing of 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 100 Model TUS-X100 Version 5.0 do not change the intended use of the device. Based upon the 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.