Cleared Traditional

K850417 - INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK (FDA 510(k) Clearance)

Class I Radiology device.

K850417 · Impact Systems Corp. · Radiology device
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Oct 1985
Decision
254d
Days
Class 1
Risk

K850417 is an FDA 510(k) clearance for the INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Impact Systems Corp. (Milwaukee, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 254 days - an extended review 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: 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 Impact Systems Corp. devices

Submission Details

510(k) Number K850417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1985
Decision Date October 16, 1985
Days to Decision 254 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 107d · This submission: 254d
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.