The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Cardiac Vx.
| Device ID | K121762 |
| 510k Number | K121762 |
| Device Name: | CARDIAC VX |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Michelle Huettner |
| Correspondent | Michelle Huettner GE MEDICAL SYSTEMS, LLC 3200 N. 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 | 2012-06-15 |
| Decision Date | 2013-01-18 |
| Summary: | summary |