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 |