Cleared Traditional

K942558 - INSTACINE (FDA 510(k) Clearance)

Class I Radiology device.

K942558 · Fidelity Medical, Inc. · Radiology device
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May 1995
Decision
364d
Days
Class 1
Risk

K942558 is an FDA 510(k) clearance for the INSTACINE. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Fidelity Medical, Inc. (Florham Park, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 364 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 Fidelity Medical, Inc. devices

Submission Details

510(k) Number K942558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1994
Decision Date May 30, 1995
Days to Decision 364 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
257d slower than avg
Panel avg: 107d · This submission: 364d
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.