Xario 200 Diagnostic Ultrasound System V5.0

• K Number: K162155
• Device Name: Xario 200 Diagnostic Ultrasound System V5.0
• Manufacturer: TOSHIBA MEDICAL SYSTEMS CORPORATION
• Date Cleared: 2016-11-01 ( 91 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diaqnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small orqans, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

Device Description

The Xario200 Model TUS-X200 and Model TUS-X200S are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.

Predicate Devices

K143027

Reference Devices

K151451

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ultrasound technology and image processing techniques like SMI, not AI/ML.

Therapeutic

No
Explanation: The device is described as a "Diagnostic Ultrasound System" indicated for "visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis," which classifies it as a diagnostic rather than a therapeutic device.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states that the device is "to provide image information for diagnosis," and the "Device Description" explicitly calls it "mobile diagnostic ultrasound systems."

SaMD (Software as a Medical Device)

No

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

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states the device is for "visualization of structures, and dynamic processes within 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 of a "mobile diagnostic ultrasound system" further supports its use for imaging the inside of 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 200 Diagnostic Ultrasound System is an in vivo diagnostic imaging device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

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

IYN, IYO, ITX

Device Description

The Xario200 Model TUS-X200 and Model TUS-X200S are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Performance Testing - Clinical Images
Representative clinical images of volunteers were obtained to demonstrate that the implementation of SMI onto the subject device performed as expected. As concluded in the study, SMI was capable of imaging low velocity flow with a significant reduction in clutter noise and was capable of imaging with a high frame rate.

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

Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices.

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

Not Found

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

K143027

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

K151451

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

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

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

November 1, 2016

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

Re: K162155

Trade/Device Name: Xario 200 Diagnostic Ultrasound System V5.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 13, 2016 Received: October 14, 2016

Dear Mr. Tadeo:

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

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

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

1

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

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

Enclosure

2

Indications for Use

510(k) Number (if known) K162155

Device Name

Xario 200 Diaqnostic Ultrasound System V5.0

Indications for Use (Describe)

The Diaqnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diaqnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small orqans, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

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

ال Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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3

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

Transducer:

Clinical Application			Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	Power	CHI	4D	Other
[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	P	P		P	4,5,6,7,8,9,11(E),12(N)
Abdominal	P	P	P	P	P	2,3	P	P	P		P	4,5,6,7,8,9,11(E),12(N)
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Intra-operative (Neuro)
Laparoscopic	P	P	P		P	2	P	P	P			5,7
Pediatric	P	P	P	P	P	2,3	P	P	P		P	4,5,6,7,8,9,11(E),12(N)
Small Organ (Note 1)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Neonatal Cephalic	P	P	P	P	P	2,3	P	P	P			5,6,7,8,11(E)
Adult Cephalic	P	P	P	P	P	3	P	P	P			7
Trans-rectal	P	P	P		P	2	P	P	P		P	4,5,6,7,8,9,12(N)
Trans-vaginal	P	P	P		P	2	P	P	P		P	4,5,6,7,8,9,12(N)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	P	3	P	P	P	P		4, 7
Cardiac Pediatric	P	P	P	P	P	3	P	P	P	P		4,7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)	P	P	P	P	P	3	P					4, 7
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 TDI

• Note 5 ApliPure
  Note 6 ApliPure Plus

Note 7 Precision Imaging

Note 8 Differential THI

Note 9 Elastography

Note 10 BEAM

Note 11 Smart 3D

Note 12 SMI

4

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

Transducer:_ PSU-25BT

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

5

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

| Clinical Application

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

6

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PSU-50BT

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

7

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PSU-70BT

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	Power	CHI	4D	Other	[Note]
Ophthalmic
Fetal	P	P	P	P	P	2	P	P	P				4,5,6,7,8,9,11(E),12(N
Abdominal	P	P	P	P	P	2	P	P	P				4,5,6,7,8,9,11(E),12(N
Intra-operative
(Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	P	P				4,5,6,7,8,9,11(E),12(N
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 TDI

Note 5 ApliPure

Note 6 ApliPure Plus

Note 7 Precision Imaging

Note 8 Differential THI

Note 9 Elastography

Note 10 BEAM

Note 11 Smart 3D

Note 12 SMI

9

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

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] |
|------------------------------------------------|-------------------|---|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E |
| Abdominal | | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E |
| Small Organ (Note 1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

10

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

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | | | | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other | [Note] | |
|------------------------------------------------|-------------------|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-------|--------|---------------------|
| B | M | PWD | CWD | Color
Doppler | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | | 5,6,7,8,11(E),12(N) |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | | 5,6,7,8,11(E),12(N) |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | | 5,6,7,8,11(E),12(N) |
| Small Organ (Note 1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

11

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

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI

Note 9 Elastography

• Note 10 BEAM
• Note 11 Smart 3D

Note 12 SMI

12

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

| Clinical Application | Mode of Operation | | | | | | | | CHI
2D | 4D | Other
[Note] | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-----------|----|-----------------|--------------|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | | | | Power |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

13

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PVU-745BTF

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	Power	CHI	4D	Other
[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

14

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PVU-745BTH

| Clinical Application
Specific

(Tracks 3)		Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	Power	CHI	4D	Other
[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

15

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PVU-745BTV

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	Power	CHI	4D	Other
[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Intra-operative (Abdominal)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			5,6,7,8,11(E)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI

Note 9 Elastography

• Note 10 BEAM
• Note 11 Smart 3D

Note 12 SMI

16

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer: PVU-681MVL

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	Power	CHI	4D	Other
[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	2	P	P	P		P	5,6,7,8,12(N)
Trans-vaginal	P	P	P	P	P	2	P	P	P		P	5,6,7,8,12(N)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

17

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer: PVU-770ST

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

18

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic Flow	Power	CHI	4D	Other [Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,12(N)
Trans-vaginal	P	P	P	P	P	2	P	P	P			4,5,6,7,8,9,12(N)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

19

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	Power	CHI	4D	Other [Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	E	E	E	E	2	E	E	E			4,5,6,7,8,9,12(N)
Trans-vaginal	E	E	E	E	2	E	E	E			4,5,6,7,8,9,12(N)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

20

System: _Xario 200 TUS-X200, TUS-X200S V5.0 Transducer: PVL-715RS

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	Power	CHI	4D	Other
[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	2	P	P	P			5,6,7,8,12(Note)
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

21

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	Power	CHI	4D	Other
[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P	P	P	2	P	P	P				5,6,7,8,10,11(E),12(N)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)	P	P	P	P	P	2	P	P	P				5,6,7,8,10,11(E),12(N)
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	P	P				5,6,7,8,10,11(E),12(N)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	P	P				5,6,7,8,10,11(E),12(N)
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

22

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer: PLU-1005BT

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	Power	CHI	4D	Other [Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D Note 12 SMI

23

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

Clinical Application	Mode of Operation
Specific
(Tracks 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify) *	THI	Advanced
Dynamic
Flow	Power	CHI	4D	Other
[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Musculo-skeletal (Superficial)	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	P	P			4,5,6,7,8,9,10,11(E),12(N)
Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

• Note 4 TDI
• Note 5 ApliPure

Note 6 ApliPure Plus

• Note 7 Precision Imaging
  Note 8 Differential THI

• Note 9 Elastography
  Note 10 BEAM

Note 11 Smart 3D

Note 12 SMI

24

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

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

25

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

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

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

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

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
• Note 4 TDI
• Note 5 ApliPure
• Note 6 ApliPure Plus
• Note 7 Precision Imaging
• Note 8 Differential THI
• Note 9 Elastography
• Note 10 BEAM
• Note 11 Smart 3D
• Note 12 SMI

26

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

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD

Note 4 TDI

Note 5 ApliPure

Note 6 ApliPure Plus

Note 7 Precision Imaging

Note 8 Differential THI

Note 9 Elastography

Note 10 BEAM

Note 11 Smart 3D

Note 12 SMI

27

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

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
  Note 4 TDI

• Note 5 ApliPure
  Note 6 ApliPure Plus

Note 7 Precision Imaging

Note 8 Differential THI

Note 9 Elastography

Note 10 BEAM

Note 11 Smart 3D

Note 12 SMI

28

System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PC-50M

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

• Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
  Note 4 TDI

• Note 5 ApliPure
  Note 6 ApliPure Plus

Note 7 Precision Imaging

Note 8 Differential THI

Note 9 Elastography

Note 10 BEAM

Note 11 Smart 3D

Note 12 SMI

29

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

510(k) SUMMARY

• SUBMITTER'S NAME: 1. Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550
• 2. 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 [phone]

• 5. Date Prepared:
     October 13, 2016

6. TRADE NAME(S):

Xario 200 Diagnostic Ultrasound System V5.0

7. COMMON NAME:

System, Diagnostic Ultrasound

DEVICE CLASSIFICATION: 8.

Class II

Ultrasonic Pulsed Doppler Imaging System – Product Code: 90-IYN [per 21 CFR 892.1550] Ultrasonic Pulsed Echo Imaging System – Product Code: 90-IYO [per 21 CFR 892.1560] Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [per 21 CFR 892.1570]

30

9. PREDICATE DEVICE:

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

Reference Device

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

10. REASON FOR SUBMISSION:

Modification of a cleared device

11. DEVICE DESCRIPTION:

The Xario200 Model TUS-X200 and Model TUS-X200S are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.

12. INDICATIONS FOR USE:

The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric, transesoph(cardiac) and peripheral vessel.

13. SUBSTANTIAL EQUIVALENCE:

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

31

| | Xario 200
Model TUS-X200,
TUS-X200S v3.0 | Xario 200
Model TUS-X200
v5.0 | Xario 200
Model TUS-X200S
v5.0 | Comment |
|---------------------------|------------------------------------------------|-------------------------------------|--------------------------------------|----------------------------------------------------------------|
| 510(K) Control
Number | K143027
(Predicate Device) | N/A
(Subject Device) | N/A
(Subject Device) | |
| Precision Plus
Imaging | No | Yes | No | Image quality
improvement(s) to
existing feature |
| Monitor | 19 inch LCD
(CCFL backlight) | 19 inch LCD
(LED backlight) | 19 inch LCD
(LED backlight) | New hardware |
| PET-512MD
Transducer | Not Available | Available | Available | New TEE
transducer,
similar to
PET-512MC
(K103629) |

Previously cleared software options being implemented to the subject device:

Application	510(k) Clearance	Comments
Superb Micro Vascular Imaging	Previously cleared under
K151451	Available on Model TUS-
X200 only
Luminance	Previously cleared under
K151451	N/A

14. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 (2005), IEC 60601-1-2:2007, IEC 60601-2-37 (2007), IEC 62304 (2006), AIUM RTD2-2004 Output Display and ISO 10993-1 standards.

15. TESTING

Design Control Activities including risk management following ISO14971, verification/validation testing and Acoustic Output testing (UD3, 2004) were conducted and included in this submission.

Performance Testing - Clinical Images

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

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

Additionally, testing of the modified system was conducted in accordance with the

32

applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices.

16. CONCLUSION

The modifications incorporated into the Xario 200 Model TUS-X200 Version 5.0 and Xario200 Model TUS-X200S Version 5.0 do not change the intended use of the device. Based upon the acquisition of representative clinical images, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use.