Cleared Traditional

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

Class I Radiology device.

K933115 · Eigen · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
286d
Days
Class 1
Risk

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

Submitted by Eigen (Nevada City, US). The FDA issued a Cleared decision on April 7, 1994 after a review of 286 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2010 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eigen devices

Submission Details

510(k) Number K933115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 107d · This submission: 286d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LMB Device, Digital Image Storage, Radiological
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LMB Device, Digital Image Storage, Radiological

Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K933115.
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
K972380 · Eastman Kodak Company · Sep 1997
OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS
K952888 · Olympus America, Inc. · Sep 1995
KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM
K914728 · Eastman Kodak Company · Mar 1992
KODAK EKTASCAN IMAGE MANAGER
K891690 · Eastman Kodak Company · Jun 1989
KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET
K873048 · Eastman Kodak Company · Oct 1987
ERS SYSTEM
K863286 · General Electric Co. · Oct 1986