Device, Storage, Images, Ophthalmic
The Device, Storage, Images, Ophthalmic (product code NFF) is a radiology/ophthalmic device used to store diagnostic ophthalmic images, such as fundus photographs or OCT scans, in digital format for archiving and retrieval. It is classified as an FDA Class 1 device within the Radiology specialty, the lowest risk category, subject to general controls and exempt from 510(k) premarket notification. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NFF
- Device Class
- FDA class 1
- Regulation Number
- 892.2010
- Medical Specialty
- Radiology
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K021787 | VISUCAM | Jun 21, 2002 | Substantially Equivalent | Carl Zeiss Ophthalmic Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.