LogoFDA 510(k) Search
K Number
K122491
Device Name
VIAMO SSA-640A V4.0
Manufacturer
TOSHIBA MEDICAL SYSTEMS CORPORATION
Date Cleared
2012-09-13

(29 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VIAMO Diagnostic Ultrasound System is indicated for the visualization of structures, characteristics and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular and musculo-skeletal (both conventional and superficial).
Device Description
Viamo V4.0 is a Track 3 ultrasound system. It is a full-digital system that utilizes a wide range of probes (flat linear array, convex array and sector array) with a frequency range of approximately 2.5 MHz to 12 MHz. The slim pole-cart allows the system to be easily moved in the medical facility to perform examinations. The main unit, which can be detached from the cart by one-touch operation, is powered by an internal battery.
More Information

K100067

Not Found

No
The document does not mention AI, ML, or any related terms in the device description or performance studies.

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

Yes
The "Intended Use / Indications for Use" section explicitly states that the system provides "image information for diagnosis."

No

The device description explicitly states it is a "full-digital system that utilizes a wide range of probes" and has a "main unit" that can be detached from a "slim pole-cart," indicating it includes significant hardware components beyond just software.

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

Here's why:

  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
  • Device Function: The VIAMO Diagnostic Ultrasound System is described as a system for the "visualization of structures, characteristics and dynamic processes within the human body using ultrasound." This is an in vivo (within the body) imaging technique.
  • Intended Use: The intended use clearly states it's for "visualization of structures... within the human body" and to "provide image information for diagnosis." This aligns with diagnostic imaging, not in vitro testing.
  • Device Description: The description details an ultrasound system with probes that are applied to the body.
  • Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD tests.

Therefore, the VIAMO Diagnostic Ultrasound System is a medical imaging device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The VIAMO Diagnostic Ultrasound System is indicated for the visualization of structures, characteristics and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular and musculo-skeletal (both conventional and superficial).

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

IYN, IYO, ITX

Device Description

Viamo V4.0 is a Track 3 ultrasound system. It is a full-digital system that utilizes a wide range of probes (flat linear array, convex array and sector array) with a frequency range of approximately 2.5 MHz to 12 MHz. The slim pole-cart allows the system to be easily moved in the medical facility to perform examinations. The main unit, which can be detached from the cart by one-touch operation, is powered by an internal battery.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

fetal, abdominal, pediatric, small organs (thyroid, breast and testicle), trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, musculo-skeletal

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)

a. Bench Test
-The B mode accuracy and Doppler mode velocity accuracy tests were conducted confirm the effectiveness for the added two transducers. And electrical, thermal tests and acoustic power test were conducted to confirm the safety.
-The accuracy test of the Vascularity Index was conducted to confirm the effectiveness.
b. Clinical Test
Viamo V4.0 did not require clinical studies to support substantial equivalence.

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.

K100067

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

510(k)-SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with 21 CFR 807.92, the following summary of the information is provided.

  • l. Submitter's Name: Toshiba America Medical Systems, Inc.
    1. Submitter's Address: 2441 Michelle Drive Tustin, CA 92781-2068
    1. Establishment Registration Number: 2020563
    1. Contact Person: Charlemagne Chua Manager Regulatory Affairs (714) 730-5000
    1. Date Prepared: July 2, 2012
    1. Manufacturer: Panasonic Healthcare Co., Ltd

Manufacturer Address 1:

600 Saedo-cho, Tsuzuki-ku Yokohama, Japan 224-8539 Establishment Registration Number: 8030237

Manufacturer Address 2:

247 Fukutake-ko Saijo, Japan 793-8510

Establishment Registration Number: 3007582674

    1. Distributor: Toshiba Medical Systems Corporation
    1. Distributer Address: 1385 Shimoishigami Otawara-Shi, Tochigi-Ken, Japan 324-8550
    1. Device Proprietary Name: VIAMO MODEL SSA-640A V4.0
    1. Common Name: Diagnostic Ultrasound System
    1. Classification: Regulatory Class: II Review Category: Tier II

JULY 2012

SEP 13 2012

1

Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-I YN [Fed.Reg.No.:892.15501 Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO [Fed.Reg.No .: 892.1560] Diagnostic Ultrasonic Transducer - Product Code: 90-1TX [Fed. Reg. No.: 892.1570]

12. Predicate Device:

Viamo SSA-640A v2.0 Ultrasound System, Toshiba America Medical Systems, Inc., K100067.

13. Device Description:

Viamo V4.0 is a Track 3 ultrasound system. It is a full-digital system that utilizes a wide range of probes (flat linear array, convex array and sector array) with a frequency range of approximately 2.5 MHz to 12 MHz. The slim pole-cart allows the system to be easily moved in the medical facility to perform examinations. The main unit, which can be detached from the cart by one-touch operation, is powered by an internal battery.

14. Indications for Use:

The VIAMO Diagnostic Ultrasound System is indicated for the visualization of structures, characteristics and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular and musculo-skeletal (both conventional and superficial).

15. Technological characteristics:

The Viamo V4.0 employs the same fundamental scientific technology as its predicate device.

16. New Feature:

Addition of two transducers:

The PVT-712BT for trans-vaginal and the PST-50BT for abdominal, pediatric, neonatal cephalic, adult cephalic, cardiac adult, cardiac pediatric are added to the Viamo.

Addition of Vascularity Index: The "Vascularity Index" provides the area of the power mode where blood is flowing.

Addition of a new display format for dual images: This is a new display format for dual image mode.

17. Determination of Substantial Equivalence:

The addition of the two transducers, PVT-712BT and PST-50BT, do not change the cleared intended use of the Viamo V2.0, K100067. And the addition of the Vascularity Index does not change the effectiveness and safety of the device.

The materials, hardware, method of operation, base software and manufacturing process remain unchanged from the predicate device. The Viamo SSA-640A V4.0

510(K): VIAMO MODEL SSA-640 V4.0 Page 18 of 2141

2

incorporates two new features including a display of the Vascularity Index and a new image display format for dual images. Additionally, two transducers were added for use with VIAMO MODEL SSA-640A V4.0. This device is substantially equivalent to the Viamo SSA-640A V2.0. K100067.

18. Safety:

This device is designed and manufactured under the Quality System Regulations as outlined under 21 CFR$820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC 60601-1(2005), IEC 60601-1-2(2007). IEC 60601-2-37(2007) and the AIUM-NEMA UD3 Output Display Standard.

19. Summary of Testing:

a. Bench Test

-The B mode accuracy and Doppler mode velocity accuracy tests were conducted confirm the effectiveness for the added two transducers. And electrical, thermal tests and acoustic power test were conducted to confirm the safety.

-The accuracy test of the Vascularity Index was conducted to confirm the effectiveness.

b. Clinical Test

Viamo V4.0 did not require clinical studies to support substantial equivalence.

20. Conclusion:

The new features being added to the subject device do not change the indication for use or the intended use of the device. Based upon the safety and effectiveness data/information provided, the clinical performance of VIAMO MODEL SSA-640A V4.0 is deemed to be substantially equivalent to the predicate device.

3

10903 New Hampshire Avenue Silver Spring, MD 20993

SEP. 13 2012

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K122491

Trade/Device Name: VIAMO MODEL SSA-640A V4.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 30, 2012 Received: August 31, 2012

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the VIAMO MODEL SSA-640A V4.0, as described in your premarket notification:

Transducer Model Number

PST-25STPLT-1204BTPLT-704ST
PVT-375STPVT-674BTPST-50BT
PLT-704STPVT-661VTPVT-712BT
PLT-805ATPVT-745BTV
PVT-382BTPVT-705BTH

4

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

If you have any questions regarding the content of this letter, please contact Gary Levine at (301) 796-6934.

Sincerely Yours,

Murhut D. Thum for

Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

5

Indications for Use

510(k) Number (if known):

Device Name:

VIAMO MODEL SSA-640A V4.0

Indications for Use:

The VIAMO Diagnostic Ultrasound System is indicated for the visualization of structures, characteristics and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular and musculo-skeletal (both conventional and superficial).

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K122491

6

System: _Viamo Model SSA-640A v4.0 Transducer:

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

| Clinical Application
Specific

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K100067

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 ApliPure

Note 4 Vascularity Index: added under this submission

(Division Sign-Off)

7

System: Viamo Model SSA-640A v4.0 PST-25ST 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
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | P | P | P | | P | 2 | P | P | P | | | 3,4 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | | P | 2 | P | P | P | | | 3,4 |
    | Small Organ (Note 1) | | | | | | | | | | | | |
    | Neonatal Cephalic | P | P | P | | P | 2 | P | P | P | | | 3,4 |
    | Adult Cephalic | P | P | P | | P | 2 | P | P | P | | | 3,4 |
    | 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 | 2 | P | P | P | | | 3,4 |
    | Cardiac Pediatric | P | P | P | | P | 2 | P | P | P | | | 3,4 |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K100067

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 ApliPure

Note 4 Vascularity Index: added under this submission

Prescription Use Only (Per 21 CRF801.109)

Michael O'Shea

Division Sig of Radiolo

210/

8

Viamo Model SSA-640A v4.0 System: Transducer: PVT-375ST

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
    2D | 3D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | P | P | P | | P | 2 | P | P | P | | | 3,4 |
    | Abdominal | P | P | P | | P | 2 | P | P | P | | | 3,4 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | | P | 2 | P | P | P | | | 3,4 |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K100067

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 ApliPure Note 4 Vascularity Index: added under this submission

Prescription Use Only (Per 21 CRF801.109)

(Division Sign-Off)
Division of Radiological Devices

510k

9

Viamo Model SSA-640A v4.0 System: _ Transducer: PLT-704ST

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
    2D | 3D | Other
    [Note] | |
    | Ophthalmic | | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | P | P | P | P | P | 2 | P | P | P | | | 3,4 | |
    | 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 | | | 3,4 | |
    | Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | | | 3,4 | |
    | 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 | | | 3,4 | |
    | Other (Specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K100067

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 ApliPure

Note 4 Vascularity Index: added under this submission

Michael D. Khan

(Division Sign-Off)
Division of Radiological Devices
510k 5122491

10

Viamo Model SSA-640A v4.0 System: PLT-805AT Transducer:

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

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWD CWDColor
DopplerCombined
(Specify)
  • | THI | Advanced
    Dynamic Flow | Power | CHI
    2D | 3D | 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 | | | 3,4 |
    | 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 | | | 3,4 |
    | Musculo-skeletal (Superficial) | P | P | P | P | 2 | P | P | P | | | 3,4 |
    | 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 | | | 3,4 |
    | Other (Specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K100067

Note 1 Small organ includes thyroid, breast and testicle. Note 1 Simall organ metados BJTCha, SPARWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure Note 4 Vascularity Index: added under this submission

NOTE 4: Vascularity index, added under this submission.

hul D. Rhu
(Division Sign-Off)

Division of Radiological Devices
510k K122499

11

Viamo Model SSA-640A v4.0 System: PVT-382BT 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
    2D | 3D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | P | P | P | | P | 2 | P | P | P | | | 3,4 |
    | Abdominal | P | P | P | | P | 2 | P | P | P | | | 3,4 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | | P | 2 | P | P | P | | | 3,4 |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K100067

Note 1 Small organ includes thyroid, breast and testicle. Note 1 Small organ invrates thyrold, brond; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure Note 4 Vascularity Index: added under this submission

If A = (255001100)

Prescription Use Only (Per 21 CRF801.109)

(Division Sign-Off)

Division of Radiological Devices

510K

12

Viamo Model SSA-640A v4.0 System: _ Transducer:_ PLT-1204BT

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)THIAdvanced
Dynamic
FlowPowerCHI
2D3DOther
[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)PPPPP2PPP3,4
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 vesselPPPPP2PPP3,4
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K100067

Note 1 Small organ includes thyroid, breast and testicle.

Note 1 Small organ uncludes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD

Note 3 ApliPure

Note 4 Vascularity Index: added under this submission

(Division Sign-Off)

Division of Radiological Devices
510k 6122491

13

Viamo Model SSA-640A v4.0 System: PVT-674BT 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
    2D | 3D | Other
    (Note) |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | P | P | P | P | P | 2 | P | P | P | | | 3,4 |
    | Abdominal | P | P | P | P | P | 2 | P | P | P | | | 3,4 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | P | P | 2 | P | P | P | | | 3,4 |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K100067

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 ApliPure

Note 4 Vascularity Index: added under this submission

Prescription Use Only (Per 21 CRF801.109)

510k

(Division Sign-Off)

Division of Radiological Devices

14

Viamo Model SSA-640A v4.0 System: PVT-661VT 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
    2D | 3D | 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 | P | P | P | P | P | 2 | P | P | P | | | 3,4 | |
    | Trans-urethral | | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Peripheral vessel | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K100067

Note 1 Small organ includes thyroid, breast and testicle. Note 1 Sman organ metades myrold, oreast and lestions.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD Note 3 ApliPure Note 3 April arty Index: added under this submission

(Division Sign-Off)

(Division Sign-Off)
Division of Radiological Devices
510k 6122489

15

Viamo Model SSA-640A v4.0 System: -PVT-745BTV Transducer:

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

Clinical ApplicationMode of Operation
Specific
(Tracks 3)BMPWD CWDColor
DopplerCombined
(Specify)THIAdvanced
Dynamic
FlowPowerCHI
2D3DOther
(Note)
Ophthalmic
Fetal
AbdominalPPPP2PPP3,4
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)
Intra-cardiac
Other (Specify)
Peripheral vesselPPPP2PPP3,4
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K100067

Note 1 Small organ includes thyroid, breast and testicle. Note 1 Small organ uictudes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure Note 4 Vascularity Index: added under this submission

(Division Sign-Off)
Division of Radiological Devices

Division of Radiological Devices
510k K122491(VP)

16

Viamo Model SSA-640A v4.0 System: PVT-705BTH 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
    2D | 3D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | P | P | P | | P | 2 | P | P | P | | | 3,4 |
    | 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) | | | | | | | | | | | | |
    | 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 transducer: K100067

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 ApliPure Note 4 Vascularity Index: added under this submission

Prescription Use Only (Per 21 CRF801.109)

510k

(Division Sign-Off)
Division of Radiological Devices

17

Viamo Model SSA-640A v4.0 System: PLT-704ST 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
    2D | 3D | Other
    [Note] | |
    | Ophthalmic | | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | | |
    | Abdominal | | | | | | | | | | | | | |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | |
    | Pediatric | | | | | | | | | | | | | |
    | Small Organ (Specify) (1) | P | P | P | P | P | 2 | P | P | P | | | | 3,4 |
    | 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 | P | P | P | P | P | 2 | P | P | P | | | | 3,4 |
    | Other (Specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K100067

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 ApliPure Note 4 Vascularity Index: added under this submission

Prescription Use Only (Per 21 CRF801.109)

510k

(Division Sign-Off)
Division of Radiological Devices

18

System: Viamo Model SSA-640A v4.0 Transducer: PST-50BT

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
    2D | 4D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | N | N | N | N | N | 2 | N | N | N | | | 3,4 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | N | N | N | N | N | 2 | N | N | N | | | 3,4 |
    | Small Organ (Note 1) | | | | | | | | | | | | |
    | Neonatal Cephalic | N | N | N | N | N | 2 | N | N | N | | | 3,4 |
    | Adult Cephalic | N | N | N | N | N | 2 | N | N | N | | | 3,4 |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | N | N | N | N | N | 2 | N | N | N | | | 3,4 |
    | Cardiac Pediatric | N | N | N | N | N | 2 | N | N | N | | | 3,4 |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |

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

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 ApliPure Note 4 Vascularity Index: added under this submission

Prescription Use Only (Per 21 CRF801.109)

(Division Sign-Off)

vision of Radiological Devices 510K

19

System: _ Viamo Model SSA-640A v4.0 Transducer: PVT-712BT

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
    2D | 3D | Other
    [Note] |
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | N | N | N | | N | 2 | N | N | N | | | 3,4 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | N | N | N | | N | 2 | N | N | N | | | 3,4 |
    | Small Organ (Specify) (1) | | | | | | | | | | | | |
    | Neonatal Cephalic | N | N | N | | N | 2 | N | N | N | | | 3,4 |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | | | | | | | | | | | | |
    | Musculo-skeletal (Superficial) | | | | | | | | | | | | |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |

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

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 ApliPure

Note 4 Vascularity Index: added under this submission

(Division Sign-Off)
Division of Radiological Devices
510k K122491