Cleared Traditional

K933115 - DIGITAL DISK RECORDER
(FDA 510(k) Clearance)

K933115 · Eigen · Radiology

Apr 1994

Decision

286d

Days

Class 1

Risk

K933115 is an FDA 510(k) clearance for the DIGITAL DISK RECORDER. This device is classified as a Device, Digital Image Storage, Radiological (Class I — General Controls, product code LMB).

Submitted by Eigen (Nevada City, US). The FDA issued a Cleared decision on April 7, 1994, 286 days after receiving the submission on June 25, 1993.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2010. Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images..

Submission Details

510(k) Number	K933115 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 1993
Decision Date	April 07, 1994
Days to Decision	286 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	LMB — Device, Digital Image Storage, Radiological
Device Class	Class I — General Controls
CFR Regulation	21 CFR 892.2010
Definition	Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.