The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Atlas Speeder Head/cervical Coil, Model Mjah-137a.
| Device ID | K083014 |
| 510k Number | K083014 |
| Device Name: | ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR Tustin, CA 92780 |
| Contact | Paul Biggins |
| 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 | 2008-10-09 |
| Decision Date | 2008-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670102707 | K083014 | 000 |