The following data is part of a premarket notification filed by Carestream Health, Inc with the FDA for Drx-compass.
| Device ID | K201373 |
| 510k Number | K201373 |
| Device Name: | DRX-Compass |
| Classification | System, X-ray, Stationary |
| Applicant | Carestream Health, Inc Building 7, No. 1510 Chuanqiao Road China (shanghai) Pilot Free Trade Zone, CN 201206 |
| Contact | Duane Gutowski |
| Correspondent | Duane Gutowski Carestream Health, Inc Building 7, No. 1510 Chuanqiao Road China (shanghai) Pilot Free Trade Zone, CN 201206 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-26 |
| Decision Date | 2020-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889978621668 | K201373 | 000 |
| 60889978624188 | K201373 | 000 |
| 60889978624195 | K201373 | 000 |
| 60889976704875 | K201373 | 000 |
| 60889976704899 | K201373 | 000 |
| 60889978624737 | K201373 | 000 |
| 60889978624744 | K201373 | 000 |
| 60889978621613 | K201373 | 000 |
| 60889978622351 | K201373 | 000 |
| 60889976701522 | K201373 | 000 |
| 60889976701539 | K201373 | 000 |
| 60889978621651 | K201373 | 000 |
| 60889978624768 | K201373 | 000 |