Cleared Traditional

K952238 - VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE) (FDA 510(k) Clearance)

Class I Radiology device.

K952238 · Imaging Concepts, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
285d
Days
Class 1
Risk

K952238 is an FDA 510(k) clearance for the VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE). Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Imaging Concepts, Inc. (Richmond, US). The FDA issued a Cleared decision on February 21, 1996 after a review of 285 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 Imaging Concepts, Inc. devices

Submission Details

510(k) Number K952238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1995
Decision Date February 21, 1996
Days to Decision 285 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
178d slower than avg
Panel avg: 107d · This submission: 285d
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.