Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.2010](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2010) → NFF — Device, Storage, Images, Ophthalmic

# NFF · Device, Storage, Images, Ophthalmic

_Radiology · 21 CFR 892.2010 · Class 1_

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

## Overview

- **Product Code:** NFF
- **Device Name:** Device, Storage, Images, Ophthalmic
- **Regulation:** [21 CFR 892.2010](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2010)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/NFF/K021787.md) | VISUCAM | Carl Zeiss Ophthalmic Systems, Inc. | Jun 21, 2002 | SESE |

## Top Applicants

- Carl Zeiss Ophthalmic Systems, Inc. — 1 clearance

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

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