The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Signa Pet/mr.
| Device ID | K213709 |
| 510k Number | K213709 |
| 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 | Brian R Zielski |
| Correspondent | Brian R Zielski 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 | 2021-11-24 |
| Decision Date | 2022-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278648877 | K213709 | 000 |
| 00195278729224 | K213709 | 000 |