The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Viamo C100 Tus-vc100 Diagnostic Ultrasound System.
| Device ID | K173962 |
| 510k Number | K173962 |
| Device Name: | Viamo C100 TUS-VC100 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Orlando Tadeo Toshiba America Medical Systems, In.c 2441 Michelle Drive Tustin, CA 92780 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-28 |
| Decision Date | 2018-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670102882 | K173962 | 000 |
| 04987670102745 | K173962 | 000 |
| 04987670102752 | K173962 | 000 |
| 04987670102769 | K173962 | 000 |
| 04987670102783 | K173962 | 000 |
| 04987670102806 | K173962 | 000 |
| 04987670102813 | K173962 | 000 |
| 04987670102820 | K173962 | 000 |
| 04987670102837 | K173962 | 000 |
| 04987670102844 | K173962 | 000 |
| 04987670102851 | K173962 | 000 |
| 04987670102868 | K173962 | 000 |
| 04987670102875 | K173962 | 000 |
| 04987670102721 | K173962 | 000 |