Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" indicated for "visualization of structures, and dynamic processes...to provide image information for diagnosis," which classifies it as a diagnostic device, not a therapeutic one.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the system provides "image information for diagnosis". Additionally, the "Device Description" explicitly calls it "mobile diagnostic ultrasound systems."

SaMD (Software as a Medical Device)

No

The device is described as a "mobile diagnostic ultrasound system" and employs "a wide array of probes," which are hardware components. The description clearly indicates it is a physical system, not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the device is for "visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis". This describes an in vivo (within the living body) diagnostic imaging system, not an in vitro (outside the living body) diagnostic test that analyzes samples like blood or tissue.
Device Description: The description confirms it's a "mobile diagnostic ultrasound system" that uses "ultrasound" to visualize structures within the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside the body, which are hallmarks of IVD devices.

Therefore, the Xario 100 Model TUS-X100 and TUS-X100S are diagnostic ultrasound systems used for imaging within the human body, not IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

# Intended Use / Indications for Use
The Diagnostic Ultrasound System Xario 100 Model TUS-X100 and 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, pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both aduit and pediatric), peripheral vascular, and musculo-skeletal (both conventional and superficial).

# Product codes
90-IYN, 90-IYO, 90-ITX

# Device Description
The Xario 100 Model TUS-X100 and 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, and sector array with frequency ranges between approximately 3 MHz to 10 MHz.

# Mentions image processing
Not Found

# Mentions AI, DNN, or ML
Not Found

# Input Imaging Modality
Ultrasound

# Anatomical Site
Fetal, abdominal, pediatric, small organs (thyroid, breast, testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult and pediatric), peripheral vascular, musculo-skeletal (conventional and superficial).

# Indicated Patient Age Range
Adult, pediatric, neonatal, fetal

# Intended User / Care Setting
Not Found

# Description of the training set, sample size, data source, and annotation protocol
Not Found

# Description of the test set, sample size, data source, and annotation protocol
Not Found

# Summary of Performance Studies
Design Control Activities including risk management following the ISO14971, verification/validation testing and Acoustic Output testing (UD3, 2004) were conducted through bench testing are included in this submission. This documentation includes testing which demonstrates that the requirements for the features have been met.

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 this device was conducted in accordance with the applicable standards published by the International Electromechnical Commission (IEC) for Medical Devices.

# Key Metrics
Not Found

# Predicate Device(s)
[K131507](https://510k.innolitics.com/search/K131507)

# Reference Device(s)
Not Found

# Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

K133277
Page 1 of 3

510(k) SUMMARY

1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
1. ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
1. ESTABLISHMENT REGISTRATION: 2020563

CONTACT PERSON: 4. Charlemagne Chua

Manager, Regulatory Affairs (714) 669-7896

1. U.S AGENT:
  Paul Biggins Director, Requlatory Affairs (714) 730-5000
1. Date Prepared: October 23, 2013

TRADE NAME(S): 7.

Diagnostic Ultrasound System Xario 100 Model TUS-X100 and TUS-X100S, SW V1.0

8. COMMON NAME:

System, Diagnostic Ultrasound

9. 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]

10. PREDICATE DEVICE:

Product	Marketed by	510(k) Number
Xario 200
(TUS-X200 and TUS-X200S), v1.0	Toshiba America
Medical Systems	K131507	August 28, 2013

1

11. REASON FOR SUBMISSION:

New device.

12. DEVICE DESCRIPTION:

The Xario 100 Model TUS-X100 and 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, and sector array with frequency ranges between approximately 3 MHz to 10 MHz.

13. SUMMARY OF INTENDED USES:

The Diagnostic Ultrasound System Xario 100 Model TUS-X100 and 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, pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both aduit and pediatric), peripheral vascular, and musculo-skeletal (both conventional and superficial).

14. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Xario 200 Diagnostic Ultrasound System, K131507, marketed by Toshiba America Medical Systems. The Xario 100 Model TUS-X100 and TUS-X100S, SW Version 1.0, functions in a manner similar to and is intended for the same use as the predicate device. The subject device is a compact diagnostic ultrasound system by implementing latest technologies.

A comparison table is included in this submission detailing the similarities and differences between the predicate device and the subject device.

15. 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 60601-2-37 (2007), IEC 62304 (2006), AIUM RTD2-2004 Output Display and ISO 10993-1 standards.

16. TESTING

Design Control Activities including risk management following the ISO14971, verification/validation testing and Acoustic Output testing (UD3, 2004) were conducted through bench testing are included in this submission. This documentation includes testing which demonstrates that the requirements for the features have been met.

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.

2

Additionally, testing of this device was conducted in accordance with the applicable standards published by the International Electromechnical Commission (IEC) for Medical Devices.

:

. .

:

.

. . . . .

ﯿﺪ

. .

.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

January 17, 2014

Toshiba Medical Systems Corporation % Mr. Charlemagne Chua Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K133277

Trade/Device Name: Xario 100, TUS-X100 and TUS-X100S V1.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 23, 2013 Received: October 24, 2013

Dear Mr. Chua:

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 and Xario 100 TUS-X100S Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

PSU-30BT	PVU-375BT	PVU-674MV
PVU-78IVT	PLU-704BT	PLU-1005BT

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.

4

Page 2-Mr. Chua

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/lygustry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safets/Reportal/roblem/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 Small Manufacturers, International and Consumer Assistance 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,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

5

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133277

Device Name

Xario 100 TUS-X 100 and TUS-X100S, v1.0

Indications for Use (Describe)

The Diagnosuc Ultrasound System 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 diagnosis in the following clinical applications: feal, abdominal, pediatric, small organs, trans-rectal, nevnatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, and musculo-skeletal (both conventional and superficial).

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

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)

	Page 001 of 008
FORM FDA 3881 (9/13)	Page 1 of 2	PSC Publishing Services (301) 443-6740 EF

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

6

510(k) Premarket Notification Xario 100 V1.0 Diagnostic Ultrasound System

System: Xario 100 TUS-X100 TUS-X100S VI.O

Transducer:

2018年08月10日 10:00:00 PM

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

Clinical Application Mode of Operation

| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | TIII | Advanced
Dynamic
Flow | Power | CIII | 4D | Other
[Note] |
|----------------------------------------|---|---|-----|-----|------------------|-----------------------|------|-----------------------------|-------|------|----|-----------------|
| Ophthalmic | | | | | N | 2 | N | N | N | | N | 5.6.7.8 |
| Fetal | N | N | N | | N | 2.3 | N | N | N | | N | 5.6.7.8 |
| Abdominal | N | N | N | N | N | 2.3 | N | N | N | | N | 5.6.7.8 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | 2.3 | N | N | N | | N | 5.6.7.8 |
| Small Organ (Note 1) | N | N | N | N | N | 2 | N | N | N | | N | 5.6.7.8.9 |
| 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 | N | N | N | | N | 2 | N | N | N | | | 4.5.7 |
| Trans-vaginal | N | N | N | | N | 2 | N | N | N | | | 4.5.7 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | N | N | N | | N | 2 | N | N | N | | | 5.6.7.8.9 |
| Musculo-skeletal
(Superficial) | N | N | N | | N | 2 | N | N | N | | | 5,6,7,8.9 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | 3 | N | N | N | | | 4.7 |
| Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | | | 4.7 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vascular
Other (Specify) | N | N | N | | N | 2 | N | N | N | | | 5.6.7.8.9 |

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

Note I Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PWD: BDF/PWD: BDF/MDF: BDF/MDF/PW1D

Note 3 Combined mode includes B/M: B/PWD: BDF/RWD: BDF/MDF: BDF/MDF/I/WD: 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

Prescription Use Only (Per 21 CFR 801.109)

Page 002 of 008

7

、

510(k) Premarket Notification

Xario 100 V1.0 Diagnostic Ultrasound System

Svstem: _ Xario 100 TUS-X100,TUS-X100S VI.0 Transduccr:_ PSU-30BT

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

| Clinical Application
Specific

(Tracks 3)	Mode of Operation
	B	M	PWD	CWD	Color
Doppler
(Specify)	Combined

| THI | Advanced
Dynamic
Flow | Power | CII | 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 | | | 4.7 |
| Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | | | 4.7 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA: F: = added under this appendix

Note I 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

Nole 4 TDI

Note 5 ApliPure

Note 6 ApliPurc Plus

Note 7 Precision Imaging

Note 8 Differential THI

Note 9 Elastography

Preseription Use Only (Per 21 CFR 801.109)

Page 003 of 008

510(k): Xarto 100 (TUS-X100 and TUS-X100S), v1.0 Page 464 of 3827

8

: • ••

510(k) Premarket Notification

Xario 100 VI.0 Diagnostic Ultrasound System

System: __Xario_100 TUS-X100,TUS-X100S V1.0 Transducer:____PV11-375BT

Intended Use: Diagnostic ultrasound imaging or Huid How analysis of the human body as follows:

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | | | | | | | | | | | Other
[Note] |
|------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-----|-----------------------------|-------|------|----|-----------------|
| | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | THI | Advanced
Dynamic
Flow | Power | CIII | 4D | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | N | N | N | | N | 2 | N | N | | N | | 5.6.7.8 |
| Abdominal | N | N | N | | N | 2 | N | N | | N | | 5.6.7.8 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | 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 vascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| | | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA: F: = 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/IVWD 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

Preseription Use Only (Per 21 CFR 801.109)

Page 004 of 008

510(k): Xario 100 (TUS-X100 and TUS-X100S), v1.0 Page 465 of 3827

9

. . ...

510(k) Premarket Notification Xario 100 V1.0 Diagnostic Ultrasound System

System: Xario 100 TUS-X100, TUS-X100S V1.0 Transducer:____ PVU-674MV

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	THI	Advanced
Dynamic
Flow	Power	CHI	4D	Other
[Note]
Ophthalmic
Fetal	N	N	N		N	2	N	N	N	N	5.6.7.8
Abdominal	N	N	N		N	2	N	N	N	N	5.6.7.8
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	2	N	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 vascular
()ther (Specify)

N = new indication: P = previously cleared by FDA: F: = 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/IVWD Note 3 Combined mode molades B/M: B/PW1): BDF/MDF: BDF/MDF: BDF/MDF/PWD: 2D/CWD: BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 ApliPurc Plus Note 7 Precision Imaging Note 8 Differential TIII Note 9 Elastography

Prescription Use Only (Per 21 CFR 801.109)

Page 005 of 008

.

510(k): Xario 100 (TUS-X100 and TUS-X1008), v1.0 Page 466 of 3827

10

、..

510(k) Premarket Notification

Xario 100 V1.0 Diagnostic Ultrasound System

System: Xario 100 TUS-X100 TUS-X100S V1.0 PVU-78IVT Transducer:____

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	THI	Dynamic
Flow	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	4.5.7
Trans-vaginal	N	N	N		N	2	N	N	N	4.5.7
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 vascular
Other (Specify)

N = new indication: P = previously cleared by I'DA: F: = added under this appendix

Note I Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M: B/PW1D: BIDF/PW1D: BDF/MDF: BDF/MDF/I'W1)

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

Prescription Use Only (Per 21 CFR 801.109)

Page 006 of 008

510(k): Xario 100 (TUS-X100 and TUS-X100S), v1.0 Page 467 of 3827

11

.,

.

510(k) Premarket Notification

Xario 100 VI.0 Diagnostic Ultrasound System

System: Xario 100 TUS-X100,TUS-X100S VI.O Transducer:_ Pl.U-704BT

Intended Use: Diagnostic ultrasound imaging or Nuid Now analysis of the human body as follows:

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | THI | Advanced
Dynamic
Flow | Power | CII | 4D | Other
[Note] | |
|------------------------------------------------|---|---|-----|-----|------------------|-----------------------|-----|-----------------------------|-------|-----|----|-----------------|---------|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | 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) | N | N | N | | N | 2 | N | N | N | | | | 5.6.7.8 |
| Musculo-skeletal (Superficial) | N | N | N | | N | 2 | N | N | N | | | | 5.6.7.8 |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vascular | N | N | N | | N | 2 | N | N | N | | | | 5.6.7.8 |
| Other (Specify) | | | | | | | | | | | | | |

N = new indication: P = previously cleared by FI)A; F: = added under this appendix

Note I 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 TI Il Note 9 Elastography

Preseription Use Only (Per 21 CFR 801.109)

Page 007 of 008

510(k): Xario 100 (TUS-X100 and TUS-X100S), v1.0 Page 468 of 3827

12

・ .. .

System: Xario 100 TUS-X100, JUS-X100S V1.0 Transducer: Pl.U-1005BT

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

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | TIII | Dynamic
Flow | Power | CHI
2D | 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 | | | 5.6.7,9 |
| 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 | | | 5,6,7,9 |
| Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | N | | | 5.6.7.9 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| 'Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vascular | N | N | N | N | N | 2 | N | N | N | | | 5.6.7.9 |
| Other (Specify) | | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA: I: = added under this appendix

Note 1 Small organ includes thyroid, breast and testicle,

Note 2 Combined mode includes B/M: B/PWD: BDF:MDF: BDF:MDF: BDF:MDF: BDF:MDF:1WD

Note 3 Combined mode includes B/M: B:PW1): BDF/MDF: BDF/MDF/W12: 2D/CW12: BDF/CW/D

Note 4 TDI
Note 5 ApliPure

Note 6 ApliPure Plus

Note 7 Precision Imaging

Note 8 Differential THI

Note 9 Elastography

Prescription Use Only (Per 21 CFR 801.109)

Page 008 of 008