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K Number
K143027
Device Name
Xario 200, V3.0
Manufacturer
TOSHIBA MEDICAL SYSTEMS CORPORATION
Date Cleared
2014-11-20

(30 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
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.
More Information

K131507, K053069

Not Found

No
The summary does not mention AI, ML, or related terms, and the description focuses on standard ultrasound technology and image processing features like needle enhancement.

No
The intended use states that the device provides "image information for diagnosis," indicating a diagnostic rather than therapeutic purpose.

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

No

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

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Function: The description clearly states that this device is a "Diagnostic Ultrasound System" that visualizes "structures, and dynamic processes with the human body using ultrasound." It uses ultrasound waves to create images of internal body parts.
  • Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the body. It operates by interacting with the body directly.

Therefore, based on the provided information, the Diaqnostic Ultrasound System Xario 200 is a medical imaging device, not an In Vitro Diagnostic device.

N/A

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, transesoph(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

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Performance Testing - 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.

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.

K131507, K053069

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.

Not Found

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

§ 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.

0

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is depicted with a modern, abstract design.

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

November 20, 2014

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

Re: K143027

Trade/Device Name: Xario 200. V3.0 (Models: TUS-X200 and TUS-X200S) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN Dated: October 20, 2014 Received: October 21, 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 200 TUS-X200, TUS-X200S V3.0 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

PSU-25BTPSU-30BTPSU-50BT
PVU-375BTPVU-382BTPVU-674BT
PVU-674MVPVU-712BTPVU-745BTF
PVU-745BTHPVU-745BTVPVU-681MVL
PVU-770STPVU-781VTPVL-715RS
PLU-704BTPLU-1005BTPLU-1204BT
PET-512MCPET-805LAPC-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

2

Indications for Use

510(k) Number (if known)

K143027

Device Name

Xario 200 TUS-X200 and TUS-X200S, V3.0

Indications for Use (Describe)

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

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

ك Prescription Use (Part 21 CFR 801 Subpart D)

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

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

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

System: Xario 200 TUS-X200,TUS-X200S V3.0

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

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    Dynamic
    Flow | Power | CHI | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | P | P | P | P | P | 2 | P | P | P | | P | 4,5,6,7,8,9 |
    | Abdominal | P | P | P | P | P | 2,3 | P | P | P | | P | 4,5,67,8,9 |
    | Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 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 | 4,5,6,7,8,9 |
    | Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10 |
    | Neonatal Cephalic | P | P | P | P | P | 2,3 | 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 | 5,6,7,8,9 |
    | Trans-vaginal | P | P | P | P | P | 2 | P | P | P | | N | 5,6,7,8,9 |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10 |
    | Musculo-skeletal
    (Superficial) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10 |
    | 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 |
    | Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers:K131507

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

Xario 200 TUS-X200, TUS-X200S V3.0 System: _ Transducer:_ PSU-25BT

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(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 (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 | 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:K131507

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

5

System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: PSU-30BT

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(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 (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 | 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:K131507

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 200 TUS-X200, TUS-X200S V3.0 Transducer: PSU-50BT

| Clinical Application | Mode of Operation | | | | | | | | | | Other
[Note] | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|-----------------|------|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)

  • | THI | Advanced
    Dynamic
    Flow | Power | CHI | | 4D |
    | 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 | 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:K131507

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 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-375BT

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)*THIAdvanced
Dynamic
FlowPowerCHI4DOther
[Note]
Ophthalmic
FetalPPPP2PPP4,5,6,7,8,
AbdominalPPPP2PPP4,5,6,7,8,
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPP2PPP4,5,6,7,8,
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 Previous 510(k) of the transducers:K131507

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 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-382BT

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    Dynamic
    Flow | Power | CHI | 4D | Other
    [Note] | |
    | Ophthalmic | | | | | | | | | | | | | |
    | Fetal | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 | |
    | Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | |
    | Pediatric | P | P | P | P | P | 2 | P | P | P | | | 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 Previous 510(k) of the transducers:K131507

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 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-674BT

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    Dynamic
    Flow | Power | CHI | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | E | E | E | E | E | 2 | E | E | E | | | 5,6,7,8 |
    | Abdominal | E | E | E | E | E | 2 | E | E | E | | | 5,6,7,8 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | E | E | E | E | E | 2 | E | E | E | | | 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 Previous 510(k) of the transducers:K131507

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 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-674MV

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWD CWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    Dynamic
    Flow | Power | CHI | 4D | Other
    [Note] | | |
    | Ophthalmic | | | | | | | | | | | | | |
    | Fetal | P | P | P P | P | 2 | P | P | P | | P | 5,6,7,8 | | |
    | Abdominal | P | 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 | P | 2 | P | P | P | | P | 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 Previous 510(k) of the transducers:K131507

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 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-712BT

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | P | P | P | P | P | 2 | P | P | P | | | 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 Previous 510(k) of the transducers:K131507

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 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-745BTF

| Clinical Application | Mode of Operation | | | | | | | | | Other
[Note] | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------------|-----|---------|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)

  • | THI | Advanced
    Dynamic
    Flow | Power | | CHI | 4D |
    | 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/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 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-745BTH

| Clinical Application
Specific

(Tracks 3)Mode of Operation
BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    Dynamic
    Flow | 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 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-745BTV

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    Dynamic
    Flow | Power | CHI | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 |
    | Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | P | P | P | P | P | 2 | P | P | P | | | 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 Previous 510(k) of the transducers:K131507

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 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-681MVL

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    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 | 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 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-770ST

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    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 | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8, |
    | Trans-vaginal | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8, |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |

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N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers:K131507

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

17

System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-781VT

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    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 | E | E | E | E | E | 2 | E | E | E | | | 5,6,7,8, |
    | Trans-vaginal | E | E | E | E | E | 2 | E | E | E | | | 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:K131507

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 200 TUS-X200, TUS-X200S V3.0 Transducer: PVL-715RS

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    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 | N | 2 | N | N | N | | | 5,6,7,8 |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |

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 200 TUS-X200, TUS-X200S V3.0 Transducer:_ PLU-704BT

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    Dynamic Flow | Power | CHI | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,1 |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,1 |
    | Musculo-skeletal (Superficial) | 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 vessel | 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:K131507

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

20

System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer:_ PLU-1005BT

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    Dynamic
    Flow | Power | CHI | 4D | Other
    [Note] | |
    | Ophthalmic | | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | E | E | E | E | E | 2 | E | E | E | | | | 4,5,6,7,8,9,10 |
    | Neonatal Cephalic | | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | E | E | E | E | E | 2 | E | E | E | | | | 4,5,6,7,8,9,10 |
    | Musculo-skeletal
    (Superficial) | E | E | E | E | E | 2 | E | E | E | | | | 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 | E | E | E | E | E | 2 | E | E | E | | | | 4,5,6,7,8,9,10 |
    | 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:K131507

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

21

System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer:_ PLU-1204BT

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    Dynamic
    Flow | Power | CHI | 4D | Other
    [Note] | |
    | Ophthalmic | | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | E | E | E | | E | 2 | E | E | E | | | | 4,5,6,7,8,9,1 |
    | Neonatal Cephalic | | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | E | E | E | | E | 2 | E | E | E | | | | 4,5,6,7,8,9,1 |
    | Musculo-skeletal
    (Superficial) | E | E | E | | E | 2 | E | E | E | | | | 4,5,6,7,8,9,1 |
    | Intravascular | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Peripheral vessel | E | E | E | | E | 2 | E | E | E | | | | 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:K131507

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 200 TUS-X200, TUS-X200S V3.0 Transducer: PET-512MC

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    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 | | | | | | | | | | | | | |
    | 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) | | | | | | | | | | | | | |

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:K131507

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 200 TUS-X200, TUS-X200S V3.0 Transducer: PET-805LA

Clinical ApplicationMode of OperationOther [Note]
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Dynamic
    Flow | Power | CHI
    2D | 4D | |
    | 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) | | | | | | | | | | | | |

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

24

System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: __ PC-20M

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

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    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 | | | | | | | | | | | | | |
    | 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:K131507

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 200 TUS-X200, TUS-X200S V3.0 Transducer: PC-50M

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

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWDCWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    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 | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | E | | | | | | | | |
    | Cardiac Pediatric | | | | E | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | | | | E | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers:K131507

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

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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 20, 2014

6. TRADE NAME(S):

Diagnostic Ultrasound System Xario200 Model TUS-X200 V3.0 Xario200 Model TUS-X200S 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]

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9. PREDICATE DEVICE:

ProductMarketed by510(k) NumberClearance Date
Xario200
Model TUS-X200, TUS-X200S, v1.0Toshiba America
Medical SystemsK131507August 28, 2013
MicroMaxx High Resolution
Ultrasound System (C3 Series)SonoSite, Inc.K053069February 24, 2006

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 V1.0 Diagnostic Ultrasound System, 510(k) cleared under K131507, marketed by Toshiba America Medical Systems. The Xario 200 Model TUS-X200 Version 3.0 and Xario 200 Model TUS-X200S 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.

Addition of Laparoscopic Use to the systems indications for use.

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14. SAFETY:

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

15. TESTING

Design Control Activities including risk management following ISO 14971, 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 Xario 200 Model TUS-X200 Version 3.0 and Xario 200 Model TUS-X200S Version 3.0 do not change the intended use of the device. Based upon bench testing, 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.