Cleared Traditional

K950630 - WALLACH DIGITAL IMAGING SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K950630 · Wallach Surgical Devices, Inc. · Radiology device
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Nov 1995
Decision
282d
Days
Class 1
Risk

K950630 is an FDA 510(k) clearance for the WALLACH DIGITAL IMAGING SYSTEM. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Wallach Surgical Devices, Inc. (Milford, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 282 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 Wallach Surgical Devices, Inc. devices

Submission Details

510(k) Number K950630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1995
Decision Date November 22, 1995
Days to Decision 282 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 107d · This submission: 282d
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.