The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Q. Freeze (motion Vue2).
| Device ID | K113408 |
| 510k Number | K113408 |
| Device Name: | Q. FREEZE (MOTION VUE2) |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | David Duersteler |
| Correspondent | David Duersteler GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-18 |
| Decision Date | 2012-02-24 |
| Summary: | summary |