Cleared Traditional

K884661 - D-SCOPE III (FDA 510(k) Clearance)

Class I Radiology device.

K884661 · Medx, Inc. · Radiology device
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Apr 1989
Decision
156d
Days
Class 1
Risk

K884661 is an FDA 510(k) clearance for the D-SCOPE III. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Medx, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on April 12, 1989 after a review of 156 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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 Medx, Inc. devices

Submission Details

510(k) Number K884661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1988
Decision Date April 12, 1989
Days to Decision 156 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 107d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
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.