Cleared Traditional

K953398 - UNISCAN (FDA 510(k) Clearance)

Class I Radiology device.

K953398 · Merlin Engineering Works, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Oct 1995
Decision
78d
Days
Class 1
Risk

K953398 is an FDA 510(k) clearance for the UNISCAN. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Merlin Engineering Works, Inc. (Palo Alto, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2020 - 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 Merlin Engineering Works, Inc. devices

Submission Details

510(k) Number K953398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1995
Decision Date October 06, 1995
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LMD System, Digital Image Communications, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2020
Definition A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. It May Provide Simple Image Review Software Functionality For Medical Image Processing And Manipulation, Such As Grayscale Window And Level, Zoom And Pan, User Delineated Geometric Measurements, Compression, Or User Added Image Annotations. The Device Does Not Perform Advanced Image Processing Or Complex Quantitative Functions.
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.