Cleared Traditional

K945654 - NICOM DIGITAL IMAGE MANAGER

K945654 is an FDA 510(k) clearance for NICOM DIGITAL IMAGE MANAGER, manufactured by Camtronics, Ltd.. The device is a Class 1 Radiology device with product code LMB cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K945654 · Camtronics, Ltd. · Radiology device
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Feb 1995
Decision
92d
Days
Class 1
Risk

K945654 is an FDA 510(k) clearance for the NICOM DIGITAL IMAGE MANAGER. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Camtronics, Ltd. (Hartland, US). The FDA issued a Cleared decision on February 17, 1995 after a review of 92 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 Camtronics, Ltd. devices

FDA 510(k) Submission Details - K945654

510(k) Number K945654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1994
Decision Date February 17, 1995
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
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 14
Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K945654.
NT SERIES DIGITAL IMAGE MANAGER
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