K142098 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 November 24, 2014, 115 days after receiving the submission on August 1, 2014.
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 | K142098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2014 |
| Decision Date | November 24, 2014 |
| Days to Decision | 115 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. |