The following data is part of a premarket notification filed by Cdr Systems, Inc. with the FDA for Cdr Systems Precision Patient Positioning System.
| Device ID | K122888 |
| 510k Number | K122888 |
| Device Name: | CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | CDR SYSTEMS, INC. #33, 235105 WRANGLER DRIVE S.W. Calgary, CA Tix Ok3 |
| Contact | Carl Denis |
| Correspondent | Carl Denis CDR SYSTEMS, INC. #33, 235105 WRANGLER DRIVE S.W. Calgary, CA Tix Ok3 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-20 |
| Decision Date | 2013-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10628341930366 | K122888 | 000 |
| 10628341930175 | K122888 | 000 |
| 10628341930168 | K122888 | 000 |
| 10628341930151 | K122888 | 000 |
| 10628341930144 | K122888 | 000 |
| 00628341930130 | K122888 | 000 |
| 00628341930109 | K122888 | 000 |
| 00628341930093 | K122888 | 000 |
| 00628341930086 | K122888 | 000 |
| 00628341930079 | K122888 | 000 |
| 00628341930062 | K122888 | 000 |
| 00628341930055 | K122888 | 000 |
| 10628341930427 | K122888 | 000 |
| 10628341930458 | K122888 | 000 |
| 10628341930441 | K122888 | 000 |
| 10628341930465 | K122888 | 000 |
| 10628341930182 | K122888 | 000 |
| 10628341930199 | K122888 | 000 |
| 10628341930359 | K122888 | 000 |
| 10628341930342 | K122888 | 000 |
| 10628341930335 | K122888 | 000 |
| 10628341930328 | K122888 | 000 |
| 10628341930304 | K122888 | 000 |
| 10628341930298 | K122888 | 000 |
| 10628341930281 | K122888 | 000 |
| 10628341930274 | K122888 | 000 |
| 10628341930267 | K122888 | 000 |
| 10628341930250 | K122888 | 000 |
| 10628341930243 | K122888 | 000 |
| 10628341930236 | K122888 | 000 |
| 10628341930229 | K122888 | 000 |
| 10628341930212 | K122888 | 000 |
| 10628341930205 | K122888 | 000 |
| 10628341930502 | K122888 | 000 |