The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Signa Pet/mr.
| Device ID | K163619 |
| 510k Number | K163619 |
| Device Name: | SIGNA PET/MR |
| Classification | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Applicant | GE Medical Systems, LLC 3200 N. Grandview Blvd. Waukesha, WI 53188 |
| Contact | Janice M. Sich |
| Correspondent | Janice M. Sich GE Medical Systems, LLC 3200 N. Grandview Blvd. Waukesha, WI 53188 |
| Product Code | OUO |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682135283 | K163619 | 000 |
| 00840682145954 | K163619 | 000 |