The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Thoracic Vcar With Gsi Pulmonary Perfusion.
| Device ID | K183210 |
| 510k Number | K183210 |
| Device Name: | Thoracic VCAR With GSI Pulmonary Perfusion |
| Classification | System, Image Processing, Radiological |
| Applicant | GE Medical Systems SCS 283 Rue De La Miniere Buc, FR 78530 |
| Contact | Peter Uhlir |
| Correspondent | Helen Peng GE Medical Systems, LLC. 3000 North Grandview Blvd Waukesha, WI 53188 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-03-29 |
| Summary: | summary |