The Diaqnostic Ultrasound System Xario 100 Model TUS-X100 and Xario 100 Model TUS-X100S are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diaqnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small orqans, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

Device Description

The Xario100 Model TUS-X100 and Model TUS-X100S are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.

AI/ML Overview

The provided text describes modifications to an ultrasound system (Xario 100 TUS-X100 and TUS-X100S V3.0) and the testing conducted to support its substantial equivalence. The information is presented in the context of a 510(k) premarket notification to the FDA.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table within the document. Instead, the document focuses on demonstrating that the modified device functions similarly to the predicate device and meets safety and performance standards. The "reported device performance" is described qualitatively as improving needle visualization.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred/Qualitative)	Reported Device Performance (Qualitative)
Intended Use Equivalence	Device maintains the same intended use as predicate devices.	The device's intended use (visualization of structures and dynamic processes for diagnosis in various clinical applications) is unchanged.
Technological Characteristics	Similar technological characteristics to predicate devices and existing transducers.	The device employs a wide array of probes (flat linear, convex linear, sector array) with frequency ranges of 2 MHz to 12 MHz, similar to its predicate. Additions include a laparoscopic transducer.
Safety and Effectiveness	Compliance with relevant safety standards and validated software.	Designed and manufactured under Quality System Regulations (21 CFR § 820, ISO 13485). Conforms to IEC60601-1, IEC 60601-1-2:2007, IEC 60601-2-37 (2007), IEC 62304 (2006), AIUM RTD2-2004, and ISO 10993-1 standards. Software validation successfully completed. Risk management applied.
Needle Visualization (BEAM feature)	The "BEAM" feature should improve needle visualization during biopsy procedures.	A study confirmed that the subject device "improves needle visualization."
Acoustic Output	Compliance with acoustic output standards.	Acoustic Output testing (UD3, 2004) was conducted.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions a "study" for the BEAM feature but does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

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

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

The document describes a study comparing "an existing imaging mode with the needle enhancement feature" but does not indicate if it was a multi-reader multi-case (MRMC) comparative effectiveness study with human readers assessing improvement with AI assistance. The "BEAM" feature is described as improving needle visualization, but no effect size or specific metrics on human reader improvement are provided.

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

The "BEAM" feature is integrated into the ultrasound system to assist in needle visualization. While the study confirmed the device's ability to improve needle visualization, it's not explicitly stated if this was a standalone algorithm-only performance evaluation, separate from how a human would then use that improved visualization. The context suggests it’s a feature within the system for human use.

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

The document does not specify the type of ground truth used for the performance study of the "BEAM" feature. It only mentions that the study "confirmed that the subject device improves needle visualization," but not how that improvement was objectively measured or validated against a ground truth.

8. The sample size for the training set

The document does not mention a training set or its sample size. This implies that the submission does not detail an AI/machine learning model in the sense of requiring a "training set" in the context of the described modifications. The "BEAM" feature might be a signal processing or image enhancement technique rather than a classic AI model requiring a distinct training phase.

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

Since no training set is mentioned (see point 8), this information is not applicable/not provided in the document.

Summary

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

November 19, 2014

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

Re: K143046

Trade/Device Name: Xario 100. V3.0 (Models: TUS-X100 and TUS-X100S) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN Dated: October 21, 2014 Received: October 22, 2014

Dear Mr. Tadeo:

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

This determination of substantial equivalence applies to the following transducers intended for use with the Xario 100 TUS-X100, TUS-X100S V3.0 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

PSU-25BT	PSU-30BT	PSU-50BT
PVU-375BT	PVU-382BT	PVU-674BT
PVU-674MV	PVU-712BT	PVU-745BTF
PVU-745BTH	PVU-745BTV	PVU-681MVL
PVU-770ST	PVU-781VT	PVL-715RS
PLU-704BT	PLU-1005BT	PLU-1204BT
PET-512MC	PET-805LA	PC-20M
PC-50M

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

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Robert A Ochs

for

Janine M. Morris 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)

K143046

Device Name

Xario 100 TUS-X100 and TUS-X100S, V3.0

Indications for Use (Describe)

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

ك Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

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Toshiba America Medical Systems, Inc.

System: _Xario 100 TUS-X100, TUS-X100S V3.0

Transducer:

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

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

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

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

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

System: _ Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PSU-25BT

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

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

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

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

Xario 100 TUS-X100,TUS-X100S V3.0 System: _

Transducer:_ PSU-30BT

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

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: K133277

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer:_ PSU-50BT

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

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

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

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

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

System: _Xario 100 TUS-X100,TUS-X100S V3.0 Transducer: PVU-375BT

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P			4,5,6,7
Abdominal	P	P	P	P	P	2	P	P	P			4,5,6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P			4,5,6,7
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vascular
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: K133277

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PVU-382BT

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

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

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PVU-674BT

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

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

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

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

System: _Xario 100 TUS-X100,TUS-X100S V3.0 Transducer: PVU-674MV

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	CHI	4D	Other[Note]
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P		P	5,6,7
Abdominal	P	P	P	P	P	2	P	P	P		P	5,6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P		P	5,6,7
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vascular
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: K133277

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PVU-712BT

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	N	N	N	N	N	2	N	N	N			5,6,7,8
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	2	N	N	N			5,6,7,8
Small Organ (Specify) (1)
Neonatal Cephalic	N	N	N	N	N	2	N	N	N			5,6,7,8
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

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PVU-745BTF

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

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 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	N	N	N	N	N	2	N	N	N			5,6,7,8
Intra-operative (Abdominal)	N	N	N	N	N	2	N	N	N			5,6,7,8
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	N	N	N	N	N	2	N	N	N			5,6,7,8
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

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PVU-745BTV

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

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer:_ PVU-681MVL

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

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PVU-770ST

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

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

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

System: Xario 100 TUS-X100,TUS-X100S V3.0 Transducer:__ PVU-781VT

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 (Specify) (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)

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: K133277

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PVL-715RS

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

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

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

System: Xario 100 TUS-X100,TUS-X100S V3.0 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 (Specify) (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)	P	P	P	P	P	2	P	P	P				5,6,7,8,1
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P				5,6,7,8,1
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vascular	P	P	P	P	P	2	P	P	P				5,6,7,8,1
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: K133277

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

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

System: Xario 100 TUS-X100,TUS-X100S V3.0 Transducer: PLU-1005BT

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,1
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			4,5,6,7,8,9,1
Musculo-skeletal(Superficial)	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,1
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vascular	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,1
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: K133277

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

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

System: _Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PLU-1204BT

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 (Specify) (1)	N	N	N	N	N	2	N	N	N			4,5,6,7,8,9,10
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			4,5,6,7,8,9,10
Musculo-skeletal(Superficial)	N	N	N	N	N	2	N	N	N			4,5,6,7,8,9,10
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			4,5,6,7,8,9,10
Other (Specify)

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

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 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 (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	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

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer:__ PET-805LA

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	DynamicFlow	Power	CHI2D	4D	Other	[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic	N	N	N		N	2	N	N	N			5,7
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 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 (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult			N
Cardiac Pediatric			N
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel			N
Other (Specify)

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

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

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

System: Xario 100 TUS-X100, TUS-X100S V3.0 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 (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult				N
Cardiac Pediatric				N
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel				N
Other (Specify)

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

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

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

TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

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

510(k) SUMMARY

1. SUBMITTER'S NAME:

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

2. OFFICIAL CORRESPONDENT Akinori Hatanaka

1. ESTABLISHMENT REGISTRATION: 9614698

CONTACT PERSON: 4.

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

5. Date Prepared:

October 21, 2014

6. TRADE NAME(S):

Diagnostic Ultrasound System Xario100 Model TUS-X100 V3.0 Xario100 Model TUS-X100S V3.0

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]

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

9. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
Xario100Model TUS-X100, TUS-X100S,v1.0	Toshiba AmericaMedical Systems	K133277	January 17,2014
MicroMaxx High ResolutionUltrasound System (C3 Series)	SonoSite, Inc.	K053069	February 24, 2006

10. REASON FOR SUBMISSION:

Modification of a cleared device

11. DEVICE DESCRIPTION:

12. INDICATIONS FOR USE:

The Diagnostic Ultrasound System Xario100 Model TUS-X100 and Xario100 Model TUS-X100S 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, transesoph(cardiac) and peripheral vessel.

13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Xario100 V1.0 Diagnostic Ultrasound System, 510(k) cleared under K133277, marketed by Toshiba America Medical Systems. The Xario100 Model TUS-X100 Version 3.0 and Xario100 Model TUS-X100S Version 3.0 functions in a manner similar to and is intended for the same use as the predicate devices referenced within this submission.

Modifications include:

The introduction of a feature called BEAM which improves needle visualization during biopsy procedures.

Addition of transducers that are either already in the market or that are similar to transducers already in the market with regard to technological characteristics to include a laparoscopic transducer.

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Addition of Laparoscopic, Intra-Operative (Abdominal) and Trans-esoph. (Cardiac) Use to the systems indications for use.

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. This documentation includes testing which demonstrates that the requirements for the features have been met.

Performance Testing - Bench

A study was conducted to compare an existing imaging mode with the needle enhancement feature and confirmed that the subject device improves needle visualization.

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 Xario100 Model TUS-X100 Version 3.0 and Xario100 Model TUS-X100S Version 3.0 do not change the intended use of the device. Based upon bench testing, successful completion of software validation, application of risk manaqement 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.