DURADIAGNOST
System, X-ray, Stationary
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
The following data is part of a premarket notification filed by Philips Healthcare (suzhou) Co., Ltd. with the FDA for Duradiagnost.
Pre-market Notification Details
| Device ID | K141381 |
| 510k Number | K141381 |
| Device Name: | DURADIAGNOST |
| Classification | System, X-ray, Stationary |
| Applicant | PHILIPS HEALTHCARE (SUZHOU) CO., LTD. NO. 258, ZHONG YUAN RD. SUZHOU INDUSTRIAL PARK Jiangsu, CN 215024 |
| Contact | Gordon Shu |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2014-06-12 |
| Summary: | summary |
Trademark Results [DURADIAGNOST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURADIAGNOST 79114722 4441771 Live/Registered |
Koninklijke Philips N.V. 2012-05-31 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.