Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.2030](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2030) → NFH — Digitizer, Images, Ophthalmic

# NFH · Digitizer, Images, Ophthalmic

_Radiology · 21 CFR 892.2030 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/NFH

## Overview

- **Product Code:** NFH
- **Device Name:** Digitizer, Images, Ophthalmic
- **Regulation:** [21 CFR 892.2030](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2030)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/NFH](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/NFH)

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