Cleared Traditional

K923356 - MEDX ROTATIONAL GANTRY SYSTEM

K923356 is an FDA 510(k) clearance for MEDX ROTATIONAL GANTRY SYSTEM, manufactured by Bfi- Medical Waste Systems. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K923356 · Bfi- Medical Waste Systems · Radiology device
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Sep 1992
Decision
75d
Days
Class 1
Risk

K923356 is an FDA 510(k) clearance for the MEDX ROTATIONAL GANTRY SYSTEM. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Bfi- Medical Waste Systems (Wood Dale, US). The FDA issued a Cleared decision on September 21, 1992 after a review of 75 days - a notably fast clearance 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: 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 Bfi- Medical Waste Systems devices

FDA 510(k) Submission Details - K923356

510(k) Number K923356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1992
Decision Date September 21, 1992
Days to Decision 75 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 107d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

IYX Device Classification - Class 1, General Controls

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.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 71
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K923356.
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