The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Imris Mr/x-ray Head Fixation Device (hfd).
| Device ID | K113748 |
| 510k Number | K113748 |
| Device Name: | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | IMRIS, INC. 100-1370 SONY PLACE Winnipeg, Mb, CA R3t 1n5 |
| Contact | Sanjay Shah |
| Correspondent | Sanjay Shah IMRIS, INC. 100-1370 SONY PLACE Winnipeg, Mb, CA R3t 1n5 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-21 |
| Decision Date | 2012-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857534006028 | K113748 | 000 |
| 00857534006004 | K113748 | 000 |