The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Viamo Ssa-640a V4.0.
| Device ID | K122491 |
| 510k Number | K122491 |
| Device Name: | VIAMO SSA-640A V4.0 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Contact | Charlemagne Chua |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2012-08-15 |
| Decision Date | 2012-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670003523 | K122491 | 000 |
| 04987670002977 | K122491 | 000 |
| 04987670002960 | K122491 | 000 |
| 04987670002953 | K122491 | 000 |