The following data is part of a premarket notification filed by Imris, Inc. with the FDA for 1.5t Head Coil (hc150), 3t Head Coil (hc300).
| Device ID | K103506 |
| 510k Number | K103506 |
| Device Name: | 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | IMRIS, INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Contact | Thomas M Taskeris |
| Correspondent | Thomas M Taskeris IMRIS, INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-29 |
| Decision Date | 2011-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857534006530 | K103506 | 000 |
| 00857534006790 | K103506 | 000 |
| 00857534006134 | K103506 | 000 |
| 00857534006226 | K103506 | 000 |
| 00857534006233 | K103506 | 000 |
| 00857534006240 | K103506 | 000 |
| 00857534006257 | K103506 | 000 |
| 00857534006400 | K103506 | 000 |
| 00857534006417 | K103506 | 000 |
| 00857534006424 | K103506 | 000 |
| 00857534006431 | K103506 | 000 |
| 00857534006448 | K103506 | 000 |
| 00857534006523 | K103506 | 000 |
| 00857534006783 | K103506 | 000 |