NFF · Device, Storage, Images, Ophthalmic
Radiology · 21 CFR 892.2010 · Class 1
Overview
| Product Code | NFF |
|---|---|
| Device Name | Device, Storage, Images, Ophthalmic |
| Regulation | 21 CFR 892.2010 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K021787 | VISUCAM | Carl Zeiss Ophthalmic Systems, Inc. | Jun 21, 2002 | SESE |
Top Applicants
- Carl Zeiss Ophthalmic Systems, Inc. — 1 clearance
