Cleared Traditional

K942558 - INSTACINE

K942558 is an FDA 510(k) clearance for INSTACINE, manufactured by Fidelity Medical, Inc.. The device is a Class 1 Radiology device with product code LMB cleared through the Traditional 510(k) pathway after a 364-day FDA review.

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

FDA 510(k) Submission Details - K942558

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.

LMB Device Classification - Class 1, General Controls

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.

Regulatory Peers - LMB Device, Digital Image Storage, Radiological

All 22
Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K942558.
NT SERIES DIGITAL IMAGE MANAGER
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NICOM DIGITAL IMAGE MANAGER
K945654 · Camtronics, Ltd. · Feb 1995
DIGITAL DISK RECORDER
K933115 · Eigen · Apr 1994
KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM
K914728 · Eastman Kodak Company · Mar 1992