The following data is part of a premarket notification filed by Quantum Medical Imaging Divison Of Carestream with the FDA for Q-rad Radiographic System With Auto-tracker Option.
| Device ID | K151924 |
| 510k Number | K151924 |
| Device Name: | Q-Rad Radiographic System With Auto-Tracker Option |
| Classification | System, X-ray, Stationary |
| Applicant | QUANTUM MEDICAL IMAGING DIVISON OF CARESTREAM 2002-B ORVILLE DRIVE NORTH Ronkonkoma, NY 11779 |
| Contact | Mark Camirand |
| Correspondent | Pamela Papineau DELPHI MEDICAL DEVICE CONSULTING, INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-13 |
| Decision Date | 2015-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889976574621 | K151924 | 000 |
| 60889971031099 | K151924 | 000 |
| 60889971031105 | K151924 | 000 |
| 60889971036018 | K151924 | 000 |
| 60889971731500 | K151924 | 000 |
| 60889976574577 | K151924 | 000 |
| 60889976574584 | K151924 | 000 |
| 60889976574591 | K151924 | 000 |
| 60889976574607 | K151924 | 000 |
| 60889976574614 | K151924 | 000 |
| 60889971031082 | K151924 | 000 |