The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Ssa-370a/powervision 6000.
| Device ID | K991710 |
| 510k Number | K991710 |
| Device Name: | SSA-370A/POWERVISION 6000 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Paul Biggins |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-05-19 |
| Decision Date | 1999-06-03 |
| Summary: | summary |