The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Drx-1 System With Drx Plus 4343 Detectors.
| Device ID | K153142 |
| 510k Number | K153142 |
| Device Name: | Carestream DRX-1 System With DRX Plus 4343 Detectors |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CARESTREAM HEALTH, INC. 150 Verona Street Rochester, NY 14608 |
| Contact | Victoria Wheeler |
| Correspondent | Victoria Wheeler 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 | 2015-10-30 |
| Decision Date | 2015-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889974160239 | K153142 | 000 |
| 60889975950563 | K153142 | 000 |
| 60889974007510 | K153142 | 000 |
| 60889974007527 | K153142 | 000 |
| 60889974007534 | K153142 | 000 |
| 60889974007541 | K153142 | 000 |
| 60889974008487 | K153142 | 000 |
| 60889974008494 | K153142 | 000 |
| 60889974008500 | K153142 | 000 |
| 60889974008517 | K153142 | 000 |
| 60889974160208 | K153142 | 000 |
| 60889974160215 | K153142 | 000 |
| 60889974160222 | K153142 | 000 |
| 60889975950556 | K153142 | 000 |