The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Ict.
| Device ID | K130224 |
| 510k Number | K130224 |
| Device Name: | ICT |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | IMRIS, INC. 100-1370 SONY PLACE Winnipeg, Mb, CA R3t 1n5 |
| Contact | Daniel Biank |
| Correspondent | Daniel Biank IMRIS, INC. 100-1370 SONY PLACE Winnipeg, Mb, CA R3t 1n5 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-29 |
| Decision Date | 2013-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857534006219 | K130224 | 000 |