The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Mr Vessellq Xpress.
| Device ID | K122164 |
| 510k Number | K122164 |
| Device Name: | MR VESSELLQ XPRESS |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS SCS 3000 NORTH GRANDVIEW W1140 Waukesha, WI 53188 |
| Contact | Helen Peng |
| Correspondent | Helen Peng GE MEDICAL SYSTEMS SCS 3000 NORTH GRANDVIEW W1140 Waukesha, WI 53188 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2012-07-20 |
| Decision Date | 2012-09-07 |
| Summary: | summary |