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
| Device Type ID | 5416 |
| Device Name | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Physical State | The Combined Imager Includes Hardware And Software For Acquisition And Reconstruction Of Both PET And MR Images. Software For Image Fusion/registration Is Also Included |
| Technical Method | MRI Creates Images Based On The Spatial Distribution Of Hydrogen Nuclei; PET Creates Images Based On The Biodistribution Of A Radiopharmaceutical. Radiation From The MRI Is Non-ionizing Radiofrequency Radiation; Radiation From The PET Radiopharmaceut |
| Target Area | Whole Body |
| Regulation Description | Emission Computed Tomography System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OUO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5416 |
| Device | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Product Code | OUO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Emission Computed Tomography System. |
| CFR Regulation Number | 892.1200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GE HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GENERAL ELECTRIC CO. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS CAPITAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Coil | 1 |
Image Display Error / Artifact | 1 |
Insufficient Information | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Delamination | 1 |
| Total Device Problems | 6 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | GE Healthcare | II | Nov-10-2015 |
| 2 | Philips Medical Systems (Cleveland) Inc | II | Aug-31-2015 |
| 3 | Philips Medical Systems (Cleveland) Inc | II | Jun-11-2015 |