The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Drx-evolution, Model Vx3733-sys.
| Device ID | K091889 |
| 510k Number | K091889 |
| Device Name: | DRX-EVOLUTION, MODEL VX3733-SYS |
| Classification | System, X-ray, Stationary |
| 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 | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-24 |
| Decision Date | 2009-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889978602773 | K091889 | 000 |
| 60889971026170 | K091889 | 000 |
| 60889971016140 | K091889 | 000 |
| 60889978624263 | K091889 | 000 |
| 60889978624256 | K091889 | 000 |
| 60889978624249 | K091889 | 000 |
| 60889978624218 | K091889 | 000 |
| 60889978624201 | K091889 | 000 |
| 60889971741035 | K091889 | 000 |
| 60889971739469 | K091889 | 000 |
| 60889971739223 | K091889 | 000 |
| 60889971035141 | K091889 | 000 |
| 60889971051301 | K091889 | 000 |
| 60889971731623 | K091889 | 000 |
| 60889978001231 | K091889 | 000 |
| 60889978001194 | K091889 | 000 |
| 60889978001170 | K091889 | 000 |
| 60889976565667 | K091889 | 000 |
| 60889976557655 | K091889 | 000 |
| 60889976551523 | K091889 | 000 |
| 60889971739254 | K091889 | 000 |
| 60889971739230 | K091889 | 000 |
| 60889971739193 | K091889 | 000 |
| 60889971731678 | K091889 | 000 |
| 60889971739216 | K091889 | 000 |