K183014 is an FDA 510(k) clearance for the uPMR 790. 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 Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 27, 2019, 119 days after receiving the submission on October 31, 2018.
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 | K183014 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2018 |
| Decision Date | February 27, 2019 |
| Days to Decision | 119 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. |