The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Stroke Vcar.
| Device ID | K152584 |
| 510k Number | K152584 |
| Device Name: | Stroke VCAR |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE Buc, FR 78530 |
| Contact | Peter Uhlir |
| Correspondent | Jeme Wallace GE HEALTHCARE 540 W Northwest Highway Barrington, IL 60010 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-10 |
| Decision Date | 2016-01-20 |
| Summary: | summary |