The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Ssa-320a Just Vision 200/ Ssa-325a Just Vision.
| Device ID | K990490 |
| 510k Number | K990490 |
| Device Name: | SSA-320A JUST VISION 200/ SSA-325A JUST VISION |
| 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 |
| Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-02-16 |
| Decision Date | 1999-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670001536 | K990490 | 000 |
| 04987670001529 | K990490 | 000 |
| 04987670001505 | K990490 | 000 |
| 04987670001499 | K990490 | 000 |
| 04987670001482 | K990490 | 000 |
| 04987670001475 | K990490 | 000 |
| 04987670000720 | K990490 | 000 |
| 04987670000713 | K990490 | 000 |