The following data is part of a premarket notification filed by Orich Medical Equipment (tianjin) Co., Ltd. with the FDA for Fs-500ddr Medical Radiographic X-ray System.
| Device ID | K152813 |
| 510k Number | K152813 |
| Device Name: | FS-500DDR Medical Radiographic X-Ray System |
| Classification | System, X-ray, Stationary |
| Applicant | ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. NO. 16 CUIMING ROAD YAT-SEN SCIENTIFIC INDUSTRIAL PARK Tianjin Economic Technological Developme, CN 301726 |
| Contact | Ju Peng |
| Correspondent | Jun Peng P&L SCIENTIFIC, INC. 6840 SW 45TH LN UNIT 5 Miami, FL 33155 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-28 |
| Decision Date | 2016-12-02 |
| Summary: | summary |