Cleared Traditional

K933256 - FAN BEAM COLLIMATOR (FDA 510(k) Clearance)

Class I Radiology device.

K933256 · Siemens Gammasonics, Inc. · Radiology device
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Oct 1993
Decision
115d
Days
Class 1
Risk

K933256 is an FDA 510(k) clearance for the FAN BEAM COLLIMATOR. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Siemens Gammasonics, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on October 29, 1993 after a review of 115 days - within the typical 510(k) review window.

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 Siemens Gammasonics, Inc. devices

Submission Details

510(k) Number K933256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1993
Decision Date October 29, 1993
Days to Decision 115 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
8d slower than avg
Panel avg: 107d · This submission: 115d
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.