← Product Code [LMB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB) · K863286

# ERS SYSTEM (K863286)

_General Electric Co. · LMB · Oct 27, 1986 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K863286

## Device Facts

- **Applicant:** General Electric Co.
- **Product Code:** [LMB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB.md)
- **Decision Date:** Oct 27, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.2010
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K863286](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K863286)

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