| Device Type ID | 5385 |
| Device Name | Device, Digital Image Storage, Radiological |
| Regulation Description | Medical Image Storage 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 | 892.2010 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LMB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5385 |
| Device | Device, Digital Image Storage, Radiological |
| Product Code | LMB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Medical Image Storage Device. |
| CFR Regulation Number | 892.2010 [🔎] |
| Device Problems | |
|---|---|
Computer Software Problem | 10 |
Patient Data Problem | 4 |
Data Problem | 4 |
Image Display Error / Artifact | 3 |
Device Operational Issue | 2 |
Missing Test Results | 1 |
Fire | 1 |
Communication Or Transmission Problem | 1 |
No Display / Image | 1 |
Device Issue | 1 |
Application Program Problem | 1 |
| Total Device Problems | 29 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ge Healthcare It | II | Sep-06-2016 |
| 2 | Ge Healthcare It | II | Dec-19-2014 |
| 3 | Merge Healthcare, Inc. | II | Apr-05-2017 |
| 4 | Merge Healthcare, Inc. | II | Mar-29-2017 |
| 5 | Merge Healthcare, Inc. | II | Mar-29-2017 |
| 6 | Merge Healthcare, Inc. | II | Mar-10-2017 |
| 7 | Merge Healthcare, Inc. | II | Aug-29-2016 |