NFI · Device, Hardcopy, Images, Ophthalmic
Radiology · 21 CFR 892.2040 · Class 2
Overview
| Product Code | NFI |
|---|---|
| Device Name | Device, Hardcopy, Images, Ophthalmic |
| Regulation | 21 CFR 892.2040 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.
Classification Rationale
Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). 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., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). 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.
