510(k) K213709 ยท OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
SIGNA PET/MR
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Jan 20, 2022 |
| Received | Nov 24, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213709
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance Open, Classified |
LNH | None listed |
| Nov 22, 2024 | GE Medical Systems, LLC Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR, Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance Open, Classified |
OUO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.