Product Code: NFG FDA class 1 21 CFR 892.2020

Device, Communications, Images, Ophthalmic

Radiology

The Device, Communications, Images, Ophthalmic (product code NFG) is a radiology/ophthalmic device that transmits or communicates ophthalmic diagnostic images between locations or systems, enabling remote review or telemedicine. 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.

510(k)s
0
FEI Numbers
19
Registration Numbers
20
Unique Applicants
0
Years Active

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Basic Information

Product Code
NFG
Device Class
FDA class 1
Regulation Number
892.2020
Medical Specialty
Radiology
Review Panel
OP
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

FEI Numbers

This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.