The following data is part of a premarket notification filed by Philips Healthcare (suzhou) Co., Ltd. with the FDA for Digitaldiagnost C50.
| Device ID | K163410 |
| 510k Number | K163410 |
| Device Name: | DigitalDiagnost C50 |
| Classification | System, X-ray, Stationary |
| Applicant | PHILIPS HEALTHCARE (SUZHOU) CO., LTD. NO. 258, ZHONG YUAN ROAD SUZHOU INDUSTRIAL PARK Suzhou, CN 215024 |
| Contact | Alina Zhou |
| Correspondent | Alina Zhou PHILIPS HEALTHCARE (SUZHOU) CO., LTD. NO. 258, ZHONG YUAN 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 | 2016-12-05 |
| Decision Date | 2017-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838082366 | K163410 | 000 |