The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation, Japan with the FDA for Octave Speeder Spine.
| Device ID | K121911 |
| 510k Number | K121911 |
| Device Name: | OCTAVE SPEEDER SPINE |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-29 |
| Decision Date | 2012-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670101465 | K121911 | 000 |