The following data is part of a premarket notification filed by Ge Medical Systems, Scs with the FDA for Stereo 3d Option For Vision Applications.
| Device ID | K152352 |
| 510k Number | K152352 |
| Device Name: | Stereo 3D Option For Vision Applications |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS, SCS 283 RUE DE LA MINIERE Buc, FR 78530 |
| Contact | Ning Wen |
| Correspondent | John Jaeckle GE MEDICAL SYSTEMS, SCS 283 RUE DE LA MINIERE Buc, FR 78530 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-20 |
| Decision Date | 2016-01-20 |
| Summary: | summary |