The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Drx-1 System.
| Device ID | K090318 |
| 510k Number | K090318 |
| Device Name: | CARESTREAM DRX-1 SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CARESTREAM HEALTH, INC. 1049 WEST RIDGE ROAD Rochester, NY 14615 |
| Contact | Christine Ehmann |
| Correspondent | Christine Ehmann CARESTREAM HEALTH, INC. 1049 WEST RIDGE ROAD Rochester, NY 14615 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-09 |
| Decision Date | 2009-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889978604784 | K090318 | 000 |
| 60889978619986 | K090318 | 000 |
| 60889971003690 | K090318 | 000 |
| 60889971003812 | K090318 | 000 |
| 60889971021229 | K090318 | 000 |
| 60889971021250 | K090318 | 000 |
| 60889971021281 | K090318 | 000 |
| 60889971035158 | K090318 | 000 |
| 60889971039187 | K090318 | 000 |
| 60889971054968 | K090318 | 000 |
| 60889971067326 | K090318 | 000 |
| 60889971740366 | K090318 | 000 |
| 60889971746146 | K090318 | 000 |
| 60889974000153 | K090318 | 000 |
| 60889974000177 | K090318 | 000 |
| 60889974000184 | K090318 | 000 |
| 60889978622795 | K090318 | 000 |