Viamo c100 TUS-VC100 Diagnostic Ultrasound System
Device Facts
| Record ID | K173962 |
|---|---|
| Device Name | Viamo c100 TUS-VC100 Diagnostic Ultrasound System |
| Applicant | Toshibamedical Systems Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Apr 20, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The Diagnostic Ultrasound System Viamo c100 Model TUS-VC100 is indication of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs (breast, transvaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult, pediatric), peripheral vascular, musculo-skeletal (conventional, superficial), and urology.
Device Story
Viamo c100 TUS-VC100 is a mobile, software-controlled, color Doppler ultrasound system. It uses electrical-acoustical-electrical transducers (linear, convex, phased arrays) to transmit ultrasonic energy into the body and receive echoes. The system processes these signals using delay-time and echo-strength analysis, incorporating Doppler and autocorrelation technology to image blood flow and overlay color-coding on B-mode grayscale images. It displays real-time images on a 15-inch color LCD monitor. Used in clinical settings by healthcare professionals, the device provides diagnostic information for various anatomical structures and dynamic processes. It supports multiple modes including B-mode (with Tissue Harmonic Imaging), M-mode, PW/CW Doppler, Color/Power Doppler, TDI, and 3D/4D. Output assists clinicians in visualizing organs and blood flow, facilitating diagnostic decision-making and biopsy guidance.
Clinical Evidence
No clinical data was required. Substantial equivalence is supported by bench testing, including electrical, mechanical, thermal, and electromagnetic compatibility safety, as well as acoustic output measurements and biocompatibility testing per ISO 10993-1.
Technological Characteristics
Mobile console with 15-inch color LCD monitor; linear, convex, and phased array transducers; electrical-acoustical-electrical sensing. Supports B, M, PW/CW Doppler, Color/Power Doppler, TDI, and 3D/4D modes. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, and NEMA UD 3. Software-controlled; moderate level of concern.
Indications for Use
Indicated for visualization of structures and dynamic processes in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), transvaginal, trans-rectal, neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal (conventional/superficial), and urology applications.
Regulatory Classification
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.
Predicate Devices
- SonoBook Series Diagnostic Ultrasound System (K170374)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the Food and Drug Administration logo. The FDA logo is in blue and contains the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
April 20, 2018
# Re: K173962
Trade/Device Name: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 22, 2018 Received: March 23, 2018
Dear Mr. Tadeo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
### K173962
#### Device Name
Viamo c100 TUS-VC100 Diagnostic Ultrasound System
#### Indications for Use (Describe)
The Diagnostic Ultrasound System Viamo c100 Model TUS-VC100 is indication of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs (breast, transvaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult, pediatric), peripheral vascular, musculo-skeletal (conventional, superficial), and urology.
| <span style="font-size:12px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------|-----------------------------------------------|
|------------------------------------------------------------------------------------|-----------------------------------------------|
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Type of Use (Select one or both, as applicable)
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# Diagnostic Ultrasound Indications For Use
# System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | Mode of Operation | | | | | | | | |
|---------------------------|-------------------------------------------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | | N | N | N | 3 | |
| | Abdominal | N | N | N | | N | N | N | 4,5 | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | | |
| | Small Organ[1] (Specify) | N | N | N | | N | N | N | 2,4,5 | |
| | Neonatal Cephalic | N | N | N | N | N | N | N | 4,5,6 | |
| | Adult Cephalic | N | N | N | N | N | N | N | 4,5,6 | |
| | Trans-rectal | N | N | N | | N | N | N | 5 | |
| | Trans-vaginal | N | N | N | | N | N | N | 5 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional)<br>Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 4,5 | |
| | Other (Urology) | N | N | N | | N | N | N | 4,5 | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | 4,5,6 | |
| | Cardiac Pediatric | N | N | N | N | N | N | N | 4,5,6 | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 4,5 | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B+M, B+CFM ,B+PW , CW, B+Color M, B/BC,B+CFM+PW ,B+PDI or DPD+PW 2. Small Organ: thyroid, testes, breast
3.4D
4. Includes guidance of biopsy (2D)
5. THI
6. TDI
Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (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 Diagnostics and Radiological Health (OIR)
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### System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | | N | N | N | |
| | Abdominal | N | N | N | | N | N | N | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ1 (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | N | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
### Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
P = previously cleared by FDA; N = new indication; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW
2. Small Organ: thyroid, testes, breast
3. Includes guidance of biopsy (2D)
4. THI
Prescription Use _ _ X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 Diagnostics and Radiological Health (OIR)
{5}------------------------------------------------
#### System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PLU-704ST
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | Other |
|---------------------------|------------------------------------|---|-------------------|---------------|---------------|------------------|------------------|-------------------|-------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | 3,4 | |
| | Small Organ[1] (Specify) | N | N | N | N | N | N | N | 2,3.4 | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | N | 3,4 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | N | 3,4 | |
| | Other (Urology) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Transesophageal | | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | N | 3.4 | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW
2. Small Organ: thyroid, testes, breast
3. Includes guidance of biopsy (2D)
4. THI
Prescription Use _ メ AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{6}------------------------------------------------
#### System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PLU-1204ST
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|---|-------------------|---------------|---------------|------------------|------------------|-------------------|-------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | 3,4 | |
| | Small Organ[1] (Specify) | N | N | N | | N | N | N | 2,3,4 | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 3,4 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 3,4 | |
| | Other (Urology) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Transesophageal | | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 3,4 | |
N = new indication; P = previously cleared by FDA;
Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW
2. Small Organ: thyroid, testes, breast
3. Includes guidance of biopsy (2D)
4. THI
Prescription Use _ メ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
E = added under this appendix
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{7}------------------------------------------------
#### System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PLU-805ST
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | 3,4 |
| | Small Organ[1] (Specify) | N | N | N | | N | N | N | 2,3,4 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 3,4 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 3,4 |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 3,4 |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW
2. Small Organ: thyroid, testes, breast
3. Includes guidance of biopsy (2D)
4. THI
Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 Diagnostics and Radiological Health (OIR)
{8}------------------------------------------------
#### System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System PLU-1003ST Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ[1] (Specify) | N | N | N | | N | N | N | 2,3,4 | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | 3,4 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | 3,4 | |
| | Other (Urology) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Transesophageal | | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | N | 3,4 | |
P = previously cleared by FDA; N = new indication; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW
2. Small Organ: thyroid, testes, breast
3. Includes guidance of biopsy (2D)
4. THI
Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 Diagnostics and Radiological Health (OIR)
{9}------------------------------------------------
#### System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PLU-704RST
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | Other |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | N | 3 |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | N | 2,3 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
P = previously cleared by FDA; N = new indication; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW
2. Includes guidance of biopsy (2D)
3. THI
Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 Diagnostics and Radiological Health (OIR)
{10}------------------------------------------------
#### System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PVU-621VST
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | N | N | N | | N | N | N | 3 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | N | 2,3 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
P = previously cleared by FDA; N = new indication; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW
2. Includes guidance of biopsy (2D)
3. THI
Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 Diagnostics and Radiological Health (OIR)
{11}------------------------------------------------
#### System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PVU-781VST
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | Other |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | N | N | N | | N | N | N | 3 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | N | 2,3 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
P = previously cleared by FDA; N = new indication; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW
2. Includes guidance of biopsy (2D)
3. THI
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 Diagnostics and Radiological Health (OIR)
{12}------------------------------------------------
#### System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PSU-30ST
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | N | N | N | N | N | N | N | 2,3,4 |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | 2,3,4 |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B+M. B+CFM ,B+PW , CW , B+Color M, B/BC,B+CFM+PW ,B+PDI or DPD+PW 2. Includes guidance of biopsy (2D)
3. THI
4. TDI
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 Diagnostics and Radiological Health (OIR)
{13}------------------------------------------------
#### Viamo c100 TUS-VC100 Diagnostic Ultrasound System System: PSU-60ST Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | N | 2,3,4 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | N | N | N | N | N | N | N | 2,3,4 |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
N = new indication; P = previously cleared by FDA;
E = added under this appendix
Note : 1. Combined modes are B+M, B+CFM ,B+PW , CW , B+Color M, B/BC,B+CFM+PW ,B+PDI or DPD+PW 2. Includes guidance of biopsy (2D)
3. THI
4. TDI
Prescription Use メ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 Diagnostics and Radiological Health (OIR)
{14}------------------------------------------------
#### System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PVU-682ST
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | N | N | N | | N | N | N | 2,3 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | N | 2,3 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
### Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW, B/BC,B+CFM+PW ,B+PDI or DPD+PW
2. Includes guidance of biopsy (2D)
3. THI
Prescription Use __ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 Diagnostics and Radiological Health (OIR)
{15}------------------------------------------------
#### System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PC-20ST
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | N | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | N | | | | |
| | Cardiac Pediatric | | | | N | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | N | | | | |
### Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication;
P = previously cleared by FDA;
E = added under this appendix
× Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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 Diagnostics and Radiological Health (OIR)
{16}------------------------------------------------
#### System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PVU-574MST
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|-------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | | N | N | N | 2 |
| | Abdominal | N | N | N | | N | N | N | 3,4 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | N | 3,4 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Transesophageal | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | |…
