Cleared Traditional

K931410 - NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K931410 · Novus Technologies, Inc. · Radiology device
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Feb 1994
Decision
336d
Days
Class 1
Risk

K931410 is an FDA 510(k) clearance for the NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Novus Technologies, Inc. (San Leandro, US). The FDA issued a Cleared decision on February 18, 1994 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Novus Technologies, Inc. devices

Submission Details

510(k) Number K931410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1993
Decision Date February 18, 1994
Days to Decision 336 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
229d slower than avg
Panel avg: 107d · This submission: 336d
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.