NFH · Digitizer, Images, Ophthalmic
Radiology · 21 CFR 892.2030 · Class 2
Overview
| Product Code | NFH |
|---|---|
| Device Name | Digitizer, Images, Ophthalmic |
| Regulation | 21 CFR 892.2030 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.
Classification Rationale
Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
