The following data is part of a premarket notification filed by Orich Medical Equipment (tianjin Co., Ltd. with the FDA for Radiographic X-ray System.
| Device ID | K120034 |
| 510k Number | K120034 |
| Device Name: | RADIOGRAPHIC X-RAY SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | ORICH MEDICAL EQUIPMENT (TIANJIN CO., LTD. 6840 SW 45TH LN #5 Miami, FL 33155 |
| Contact | Jun Peng |
| Correspondent | Jun Peng ORICH MEDICAL EQUIPMENT (TIANJIN CO., LTD. 6840 SW 45TH LN #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 | 2012-01-04 |
| Decision Date | 2012-04-17 |
| Summary: | summary |