| Device Type ID | 5384 |
| Device Name | Digitizer, Image, Radiological |
| Regulation Description | Medical Image Digitizer. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 892.2030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LMA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5384 |
| Device | Digitizer, Image, Radiological |
| Product Code | LMA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Image Digitizer. |
| CFR Regulation Number | 892.2030 [🔎] |