K163234 is an FDA 510(k) clearance for the Biograph mMR with syngo MR E11P system software. 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 Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on February 28, 2017, 103 days after receiving the submission on November 17, 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 | K163234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2016 |
| Decision Date | February 28, 2017 |
| Days to Decision | 103 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. |