K163619 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 February 14, 2017, 54 days after receiving the submission on December 22, 2016.
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 | K163619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2016 |
| Decision Date | February 14, 2017 |
| Days to Decision | 54 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. |