MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
Device Facts
| Record ID | K100067 |
|---|---|
| Device Name | MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM |
| Applicant | Toshiba America Medical Systems, In.C |
| Product Code | ITX · Radiology |
| Decision Date | Jan 28, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
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).
Device Story
Viamo SSA-640 v2.0 is a mobile diagnostic ultrasound system; utilizes various probes (linear, convex, sector arrays) with 2.5-12 MHz frequency range. Operates as a Track 3 device; performs B-mode, M-mode, PWD, CWD, Color Doppler, and THI imaging. Used in clinical settings by healthcare professionals for visualization of human body structures and dynamic processes. Provides real-time image information for diagnostic decision-making. Includes ApliPure imaging enhancement. System is mobile, facilitating point-of-care use.
Clinical Evidence
Bench testing only. No clinical data presented. Compliance with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-37, and AIUM-NEMA UD2/UD3 standards confirmed.
Technological Characteristics
Mobile ultrasound system; frequency range 2.5-12 MHz. Transducers: linear, convex, sector arrays. Modes: B, M, PWD, CWD, Color Doppler, THI, Power, ApliPure. Standards: IEC 60601-1, IEC 62304, AIUM-NEMA UD2/UD3. Track 3 system.
Indications for Use
Indicated for fetal, abdominal, pediatric, small organ (thyroid, breast, testicle), trans-vaginal, neonatal/adult cephalic, cardiac, peripheral vascular, and musculoskeletal (conventional/superficial) imaging in patients requiring diagnostic ultrasound or fluid flow analysis.
Regulatory Classification
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.
Predicate Devices
- Toshiba Ultrasound Diagnostic System Viamo Model SSA-640 v1.2 (K093171)
- Toshiba Ultrasound Diagnostic System Aplio XG Model SSA-790A V4.0 (K091295)
Submission Summary (Full Text)
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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.
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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-704AT | PVT-674BT | PLT-704ST |
|------------|------------|-----------|
| PVT-705BTH | PLT-1204BT | PVT-375ST |
| PVT-745BTV | PVT-382BT | PST-25ST |
| PVT-661VT | PLT-805AT | |
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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)
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# 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
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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<br>Specific<br>(Tracks 3) | Mode of Operation | | | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[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<br>(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
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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<br>Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[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<br>(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 Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[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<br>(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
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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 Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[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<br>(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
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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<br>Specific<br>(Tracks 3) | B | M | PWD | CWD | Color.<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[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<br>(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<br>Specific<br>(Tracks 3) | Mode of Operation | | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[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<br>(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 Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[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<br>(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 Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[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<br>(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∂∂<7
{12}------------------------------------------------
510(k) Premarket Notification Viamo (v2.0) SSA-640A Ultrasound System
System: Viamo v2.0 SSA-640A Transducer: PVT-661VT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------|----|-----------------|---|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | N | N | N | N | N | 2 | | N | N | N | | | 3 |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal<br>(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 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 K10067
。「
{13}------------------------------------------------
### System: _ Viamo v2.0 SSA-640A Transducer:_ PVT-745BTV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | | | |
|------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------|----|-----------------|--|
| Specific<br>(Tracks 3) | | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[Note] | |
| Ophthalmic | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | |
| Abdominal | | P | P | P | | P | 2 | P | N | P | | | 3 | |
| 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<br>(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 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)
K.E.O.R
(Division Sign-Off) Division of Radiological Devices
510(k) Number K100067
B-11
{14}------------------------------------------------
### System: Viamo v2.0 SSA-640A Transducer:_ PVT-705BTH
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | N | P | | | 3 |
| 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<br>(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 S10(k) of the transducer: K091295
Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure : added under this submission
Prescription Use Only (Per 21 CRF801.109)
signature
(Division Sign-Off) Division of Radiological Devices
510(k) Number K/800 67
{15}--------------------…
