Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.2040](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2040) → NFI — Device, Hardcopy, Images, Ophthalmic

# NFI · Device, Hardcopy, Images, Ophthalmic

_Radiology · 21 CFR 892.2040 · Class 2_

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

## Overview

- **Product Code:** NFI
- **Device Name:** Device, Hardcopy, Images, Ophthalmic
- **Regulation:** [21 CFR 892.2040](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2040)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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._

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

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