The following data is part of a premarket notification filed by Philips Healthcare (suzhou) Co., Lit. with the FDA for Digitaldiagnost C50.
| Device ID | K201725 |
| 510k Number | K201725 |
| Device Name: | DigitalDiagnost C50 |
| Classification | System, X-ray, Stationary |
| Applicant | Philips Healthcare (Suzhou) Co., Lit. No. 258, ZhongYuan Road Suzhou Industrial Park Suzhou, CN 215024 |
| Contact | Claire Zhang |
| Correspondent | Claire Zhang Philips Healthcare (Suzhou) Co., Lit. No. 258, ZhongYuan Road Suzhou Industrial Park Suzhou, CN 215024 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-23 |
| Decision Date | 2020-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838095199 | K201725 | 000 |