The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Famio Diagnostic Ultrasound Systems, Model Ssa-530a.
| Device ID | K051500 |
| 510k Number | K051500 |
| Device Name: | FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A |
| 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 | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-06-07 |
| Decision Date | 2005-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670001789 | K051500 | 000 |
| 04987670001772 | K051500 | 000 |
| 04987670001765 | K051500 | 000 |
| 04987670001758 | K051500 | 000 |
| 04987670001741 | K051500 | 000 |
| 04987670000881 | K051500 | 000 |
| 04987670000867 | K051500 | 000 |