Cleared Traditional

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

Class I Radiology device.

K933115 · Eigen · Radiology device
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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.

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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.