NFG · Device, Communications, Images, Ophthalmic
Radiology · 21 CFR 892.2020 · Class 1
Overview
| Product Code | NFG |
|---|---|
| Device Name | Device, Communications, Images, Ophthalmic |
| Regulation | 21 CFR 892.2020 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
