The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Qd Knee/foot Coil, Model Mjqj-147a.
| Device ID | K051763 |
| 510k Number | K051763 |
| Device Name: | QD KNEE/FOOT COIL, MODEL MJQJ-147A |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Michaela Mahl |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-06-30 |
| Decision Date | 2005-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670101595 | K051763 | 000 |