The following data is part of a premarket notification filed by Beijing Sinopharm Hundric Mediline Info. Tech. Co. with the FDA for System, X-ray, Stationary.
| Device ID | K121854 |
| 510k Number | K121854 |
| Device Name: | SYSTEM, X-RAY, STATIONARY |
| Classification | System, X-ray, Stationary |
| Applicant | BEIJING SINOPHARM HUNDRIC MEDILINE INFO. TECH. CO. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING SINOPHARM HUNDRIC MEDILINE INFO. TECH. CO. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-25 |
| Decision Date | 2012-08-22 |
| Summary: | summary |