The following data is part of a premarket notification filed by Ge Oec Medical Systems, Inc. with the FDA for Oec 3d.
| Device ID | K203346 |
| 510k Number | K203346 |
| Device Name: | OEC 3D |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | GE OEC Medical Systems, Inc. 384 N Wright Brothers Drive Salt Lake City, UT 84116 |
| Contact | Kenny M. Bello |
| Correspondent | Rachel Schandel GE OEC Medical Systems, Inc. 384 N Wright Brothers Drive Salt Lake City, UT 84116 |
| Product Code | OXO |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-13 |
| Decision Date | 2021-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278096944 | K203346 | 000 |