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K Number
K100067
Device Name
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
Manufacturer
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
2010-01-28

(17 days)

Product Code
ITXIYNIYO
Regulation Number
892.1570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viamo SSA-640 v2.0 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 musculoskeletal (both conventional and superficial).
Device Description
The Viamo is a mobile system. It is a Track 3 device that employs a wide range of probes that include flat linear array, convex array and sector array with a frequency range of approximately 2.5 MHz to 12 MHz.
More Information

K093171, K091295

Not Found

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

No
The device is used for visualization and diagnosis, not for treating or curing a medical condition.

Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used "to provide image information for diagnosis."

No

The device description explicitly states it is a "mobile system" that "employs a wide range of probes," indicating it includes hardware components beyond just software.

Based on the provided information, the Viamo SSA-640 v2.0 Ultrasound System 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 to provide information for diagnosis, monitoring, or screening.
  • Viamo's Function: The Viamo system uses ultrasound to visualize structures within the human body. It does not analyze samples taken from the body.
  • Intended Use: The intended use clearly states "visualization of structures, characteristics, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis". This describes an in vivo (within the living body) diagnostic imaging system, not an in vitro diagnostic test.

Therefore, the Viamo SSA-640 v2.0 Ultrasound System is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Viamo SSA-640 v2.0 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 musculoskeletal (both conventional and superficial).

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

  • Fetal
  • Abdominal
  • Pediatric
  • Small Organ (Note 1)
  • Neonatal Cephalic
  • Adult Cephalic
  • Trans-vaginal
  • Musculo-skeletal (Conventional)
  • Musculo-skeletal (Superficial)
  • Cardiac Adult
  • Cardiac Pediatric
  • Peripheral vessel

Note 1 Small organ includes thyroid, breast and testicle.

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

90-IYN, 90-IYO, 90-ITX

Device Description

The Viamo is a mobile system. It is a Track 3 device that employs a wide range of probes that include flat linear array, convex array and sector array with a frequency range of approximately 2.5 MHz to 12 MHz.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organs (thyroid, breast, testicle), Trans-vaginal, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculoskeletal (conventional and superficial)

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Prescription Use

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)

Not Found

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.

K093171, K091295

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

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

0

K100067

510(k) Premarket Notification Viamo (2.0) SSA-640A Ultrasound System

510(k) Summary

Submitter's Name:Toshiba America Medical Systems, Inc.JAN 2 8 2010
Address:2441 Michelle Drive, Tustin, CA 92780
Contact:Paul Biggins, Director Regulatory Affairs
Telephone No .:(714) 730-5000
Device Proprietary Name:VIAMO MODEL SSA-640A Version 2.0-
Common Name:Diagnostic Ultrasound System

Classification:

  • . Regulatory Class: II
  • Review Category: Tier II . ●
  • . Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [Fed. Reg.No .: 892.1550]
  • . Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO [Fed. Reg.No .: 892.1560]
  • . Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [Fed. Reg. No .: 892.1570]

Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to:

  • Toshiba Ultrasound Diagnostic System Viamo Model SSA-640 v1.2 510(k) K093171 .
  • Toshiba Ultrasound Diagnostic System Aplio XG Model SSA-790A V4.0 510(k) K091295 .

Device Description:

The Viamo is a mobile system. It is a Track 3 device that employs a wide range of probes that include flat linear array, convex array and sector array with a frequency range of approximately 2.5 MHz to 12 MHz.

Intended Use:

The Viamo SSA-640 v2.0 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 musculoskeletal (both conventional and superficial).

Declaration of Conformity:

This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-1 (applicable portion), IEC 60601-1-2 (applicable portion), IEC 60601-1-4 (applicable portion), IEC60601-2-37 (applicable portions), IEC 62304 (applicable portion) and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.

1

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

JAN 2 8 2010

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

Re: K100067

Trade/Device Name: Viamo SSA-640 v2.0 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: January 8, 2010 Received: January 11, 2010

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 (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 SSA-640 v2.0 Ultrasound System, as described in your premarket notification:

Transducer Model Number

PLT-704ATPVT-674BTPLT-704ST
PVT-705BTHPLT-1204BTPVT-375ST
PVT-745BTVPVT-382BTPST-25ST
PVT-661VTPLT-805AT

2

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 (1 vire 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 not the Act or any Federal statutes and regulations administered by other Federal agencies. Your 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/uccn1118000.html 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 Paul Hardy at (301) 796-6542.

Sincerely yours.

Donald J. Trump

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

3

Indications for Use

510(k) Number (if known): K100067

Device Name: Viamo SSA-640 v2.0 Ultrasound System

Indications for Use:

The Viamo SSA-640 v2.0 Ultrasound System is indicated for the visualization of structures, characteristics, and dynamic processes with the human body using ultrassund on survivide mage information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, smill organs, trans-vaginal, neonatal cephalic, cardiac, cardiac, cardiac, peripheral vascular, and musculo-sketal (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) . tt

(Division Sign-Off) Division of Radiological Devices

510(k) Number

Page 1 of

4

510(k) Premarket Notification Viamo (v2.0) SSA-640A Ultrasound System

System: Viamo v2.0 SSA-640A

Transducer:

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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k): K093171

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure: added under this submission

Prescription Use Only (Per 21 CRF801.109)

signature

(Division Sign-Off) Division of Radiological Devices

510(k) Number K100827

B-2

5

System: Viamo v2,0 SSA-640A Transducer:_ PST-25ST

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

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)

  • | THI | Advanced
    Dynamic
    Flow | Power | CHI
    2D | 4D | Other
    [Note] |
    |------------------------------------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------|----|-----------------|
    | Ophthalmic | | | | | | | | | | | | |
    | Fetal | | | | | | | | | | | | |
    | Abdominal | P | P | P | | P | 2 | P | N | P | | | 3 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | | P | 2 | P | N | P | | | 3 |
    | Small Organ (Note 1) | | | | | | | | | | | | |
    | Neonatal Cephalic | P | P | P | | P | 2 | P | N | P | | | 3 |
    | Adult Cephalic | P | P | P | | P | 2 | P | N | P | | | 3 |
    | 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 | N | P | | | 3 |
    | Cardiac Pediatric | P | P | P | | p | 2 | P | N | P | | | 3 |
    | 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: K093171

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

signature

(Division Sign-Off) Division of Radiological Devices

510(k) Number

6

510(k) Premarket Notification Viamo (v2.0) SSA-640A Ultrasound System

System: Viamo v2.0 SSA-640A PVT-375ST 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 | N | P | | | 3 |
    | Abdominal | P | P | P | | P | 2 | P | N | P | | | 3 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | | P | 2 | P | N | P | | | 3 |
    | 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: K093171

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 : added under this submission

Prescription Use Only (Per 21 CRF801.109)

R.A.R

(Division Sign-Off) Division of Radiological Devices

510(k) Number frood

7

510(k) Premarket Notification Viamo (v2.0) SSA-640A Ultrasound System

System: Viamo v4.0 SSA-640A 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 | 2 | P | N | P | | | 3 |
    | Neonatal Cephalic | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | P | P | P | | P | 2 | P | N | P | | | 3 |
    | Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | N | P | | | 3 |
    | Intravascular | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | |
    | Peripheral vessel | P | P | P | | P | 2 | P | N | P | | | 3 |
    | Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K093171

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/ BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

signature

(Division Sign-Off) Division of Radiological Devices

510(k) Number_k) 00017

8

System: Viamo v2.0 SSA-640A Transducer: PLT-805AT

: ১

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

| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color.
Doppler | Combined
(Specify)

  • | THI | Advanced
    Dynamic
    Flow | Power | CHI
    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 | N | P | | | | 3 |
    | Neonatal Cephalic | | | | | | | | | | | | | |
    | Adult Cephalic | | | | | | | | | | | | | |
    | Trans-rectal | | | | | | | | | | | | | |
    | Trans-vaginal | | | | | | | | | | | | | |
    | Trans-urethral | | | | | | | | | | | | | |
    | Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
    | Musculo-skeletal
    (Conventional) | P | P | P | | P | 2 | P | N | P | | | | 3 |
    | Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | N | P | | | | 3 |
    | Intravascular | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Cardiac Adult | | | | | | | | | | | | | |
    | Cardiac Pediatric | | | | | | | | | | | | | |
    | Intravascular (Cardiac) | | | | | | | | | | | | | |
    | Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
    | Intra-cardiac | | | | | | | | | | | | | |
    | Other (Specify) | | | | | | | | | | | | | |
    | Peripheral vessel | P | P | P | | P | 2 | P | N | P | | | | 3 |
    | Other (Specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K093171

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 : added under this submission

Prescription Use Only (Per 21 CRF801.109)

DHD

(Division Sign-Off) Division of Radiological Devices

510(k) Number_ #100067

. ' 。

9

System: Viamo v2.0 SSA-640A Transducer: PVT-382BT

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

| Clinical Application
Specific
(Tracks 3) | Mode of Operation | | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)

  • | THI | Advanced
    Dynamic
    Flow | Power | CHI
    2D | 3D | Other
    [Note] |
    |------------------------------------------------|-------------------|--|---|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------|----|-----------------|
    | Ophthalmic | | | | | | | | | | | | | | |
    | Fetal | | | P | P | P | | P | 2 | P | N | P | | | 3 |
    | Abdominal | | | P | P | P | | P | 2 | P | N | P | | | 3 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | | | |
    | Pediatric | | | P | P | P | | P | 2 | P | N | P | | | 3 |
    | 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: K091371

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/PWD; BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

ty B

(Division Sign-Off) Division of Radiological Devices

510(k) Number K160647

10

System: _ Viamo v2.0 SSA-640A 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)
  • | 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 | N | P | | | 3 |
    | 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 | 2 | P | N | P | | | 3 |
    | Other (Specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

D.H.R.

(Division Sign-Off) Division of Radiological Devices

510(k) Number $k_{1} 00067$

11

Viamo v2.0 SSA-640A System: Transducer: PVT-674BT

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 | N | P | | | 3 |
    | Abdominal | P | P | P | | P | 2 | P | N | P | | | 3 |
    | Intra-operative (Abdominal) | | | | | | | | | | | | |
    | Intra-operative (Neuro) | | | | | | | | | | | | |
    | Laparoscopic | | | | | | | | | | | | |
    | Pediatric | P | P | P | | P | 2 | P | N | P | | | 3 |
    | 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: K091295

Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BIM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/ BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

2012

(Division Sign-Off) Division of Radiological Devices

510(k) Number K/r∂∂