| Device Type ID | 5386 |
| Device Name | Camera, Multi Format, Radiological |
| Regulation Description | Medical Image Hardcopy 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 | 892.2040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LMC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5386 |
| Device | Camera, Multi Format, Radiological |
| Product Code | LMC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Image Hardcopy Device. |
| CFR Regulation Number | 892.2040 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SONY ELECTRONICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Electronic Property Issue | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Philips Medical Systems (Cleveland) Inc | II | May-13-2015 |