The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Thoracic Vcar.
| Device ID | K103480 |
| 510k Number | K103480 |
| Device Name: | THORACIC VCAR |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW Waukesha, WI 53188 |
| Contact | Stephen Slavens |
| Correspondent | Stephen Slavens GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW 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 | 2010-11-26 |
| Decision Date | 2011-03-07 |
| Summary: | summary |