The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Mt/s Carlson Spine Coil, Part # 100-50082500-01.
| Device ID | K884604 |
| 510k Number | K884604 |
| Device Name: | MT/S CARLSON SPINE COIL, PART # 100-50082500-01 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | DIASONICS, INC. 280 UTAH AVE. S. San Francisco, CA 94080 |
| Contact | Ben Khosravi |
| Correspondent | Ben Khosravi DIASONICS, INC. 280 UTAH AVE. S. San Francisco, CA 94080 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-03 |
| Decision Date | 1988-11-30 |