The following data is part of a premarket notification filed by Carestream Health,inc. with the FDA for Carestream Drx-1 System With Drx 2530c Detector.
| Device ID | K130464 |
| 510k Number | K130464 |
| Device Name: | CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CARESTREAM HEALTH,INC. 150 VERONA STREET Rochester, NY 14608 |
| Contact | Carolyn Wagner |
| Correspondent | Carolyn Wagner CARESTREAM HEALTH,INC. 150 VERONA STREET Rochester, NY 14608 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-22 |
| Decision Date | 2013-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889974000795 | K130464 | 000 |
| 60889974000078 | K130464 | 000 |
| 60889976701133 | K130464 | 000 |
| 60889978615209 | K130464 | 000 |