K213709 is an FDA 510(k) clearance for the SIGNA PET/MR. This device is classified as a Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance (Class II - Special Controls, product code OUO).
Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on January 20, 2022, 57 days after receiving the submission on November 24, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200. Imager That Generates Both Both Magnetic Resonance (mr) And Positron Emission Tomography (pet) Images And Provides Registration And Fusion Of These Images. Pet And Mr Images Can Be Acquired Either Simultaneously Or Sequentially. Anatomical Mr Images Are Used For Pet Attenuation Correction..
| 510(k) Number | K213709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2021 |
| Decision Date | January 20, 2022 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1200 |
| Definition | Imager That Generates Both Both Magnetic Resonance (mr) And Positron Emission Tomography (pet) Images And Provides Registration And Fusion Of These Images. Pet And Mr Images Can Be Acquired Either Simultaneously Or Sequentially. Anatomical Mr Images Are Used For Pet Attenuation Correction. |