Cleared Traditional

K872132 - SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS (FDA 510(k) Clearance)

Class I Radiology device.

K872132 · Sopha Medical Systems, Inc. · Radiology device
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Oct 1987
Decision
145d
Days
Class 1
Risk

K872132 is an FDA 510(k) clearance for the SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS. Classified as Holder, Radiographic Cassette, Wall-mounted (product code IXY), Class I - General Controls.

Submitted by Sopha Medical Systems, Inc. (Columbia, US). The FDA issued a Cleared decision on October 26, 1987 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1880 - 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 Sopha Medical Systems, Inc. devices

Submission Details

510(k) Number K872132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1987
Decision Date October 26, 1987
Days to Decision 145 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 107d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXY Holder, Radiographic Cassette, Wall-mounted
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1880
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.