Cleared Traditional

K843349 - ND3100 VIDEO IMAGER (FDA 510(k) Clearance)

Class I Radiology device.

K843349 · Nuclear Data, Inc. · Radiology device
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Dec 1984
Decision
112d
Days
Class 1
Risk

K843349 is an FDA 510(k) clearance for the ND3100 VIDEO IMAGER. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Nuclear Data, Inc. (Schaumburg, US). The FDA issued a Cleared decision on December 17, 1984 after a review of 112 days - within the typical 510(k) review window.

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 Nuclear Data, Inc. devices

Submission Details

510(k) Number K843349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date December 17, 1984
Days to Decision 112 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 107d · This submission: 112d
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.