| Device Type ID | 5387 |
| Device Name | System, Digital Image Communications, Radiological |
| Regulation Description | Medical Image Communications Device. |
| 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 | 892.2020 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LMD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5387 |
| Device | System, Digital Image Communications, Radiological |
| Product Code | LMD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Medical Image Communications Device. |
| CFR Regulation Number | 892.2020 [🔎] |
| Device Problems | |
|---|---|
Device Operational Issue | 5 |
Device Operates Differently Than Expected | 2 |
Loss Of Data | 2 |
Computer Software Problem | 2 |
| Total Device Problems | 11 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CompView Medical, LLC | II | Jan-13-2016 |
| 2 | Karl Storz Endoscopy | II | Jul-10-2014 |
| 3 | Siemens Medical Solutions USA, Inc | II | Jun-02-2015 |