The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Q-rad System.
| Device ID | K193574 |
| 510k Number | K193574 |
| Device Name: | Q-Rad System |
| Classification | System, X-ray, Stationary |
| Applicant | Carestream Health, Inc. Building 7, No. 1510 Chuanqiao Road China (shanghai) Pilot Free Trade Zone, CN 201206 |
| Contact | Carolyn L Wagner |
| Correspondent | Carolyn L Wagner Carestream Health, Inc. Building 7, No. 1510 Chuanqiao Road China (shanghai) Pilot Free Trade Zone, CN 201206 |
| Product Code | KPR |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-01-22 |