Cleared Traditional

K955232 - NT SERIES DIGITAL IMAGE MANAGER (FDA 510(k) Clearance)

Class I Radiology device.

K955232 · Camtronics, Ltd. · Radiology device
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Dec 1995
Decision
27d
Days
Class 1
Risk

K955232 is an FDA 510(k) clearance for the NT SERIES 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 December 11, 1995 after a review of 27 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Camtronics, Ltd. devices

Submission Details

510(k) Number K955232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1995
Decision Date December 11, 1995
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
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.