The following data is part of a premarket notification filed by Ge Hualun Medical Systems Co. Ltd with the FDA for Optima Xr646.
| Device ID | K143270 |
| 510k Number | K143270 |
| Device Name: | Optima XR646 |
| Classification | System, X-ray, Stationary |
| Applicant | GE HUALUN MEDICAL SYSTEMS CO. LTD NO.1, YONG CHANG NORTH ROAD ECONOMIC & TECHNOLOGY DEVELOPMENT ZONE Beijing, CN 100176 |
| Contact | Kenny Ma |
| Correspondent | Kenny Ma GE HUALUN MEDICAL SYSTEMS CO. LTD NO.1, YONG CHANG NORTH ROAD ECONOMIC & TECHNOLOGY DEVELOPMENT ZONE Beijing, CN 100176 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-13 |
| Decision Date | 2015-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682115339 | K143270 | 000 |