Cleared Traditional

K920731 - X-RAY TUBE ASSEMBLY CIRCLEX1.2UG

K920731 is an FDA 510(k) clearance for X-RAY TUBE ASSEMBLY CIRCLEX1.2UG, manufactured by Shimadzu Medical Systems. The device is a Class 1 Radiology device with product code ITY cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K920731 · Shimadzu Medical Systems · Radiology device
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May 1992
Decision
101d
Days
Class 1
Risk

K920731 is an FDA 510(k) clearance for the X-RAY TUBE ASSEMBLY CIRCLEX1.2UG. Classified as Assembly, Tube Housing, X-ray, Diagnostic (product code ITY), Class I - General Controls.

Submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on May 29, 1992 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1760 - 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 Shimadzu Medical Systems devices

FDA 510(k) Submission Details - K920731

510(k) Number K920731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1992
Decision Date May 29, 1992
Days to Decision 101 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 107d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

ITY Device Classification - Class 1, General Controls

Product Code ITY Assembly, Tube Housing, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1760
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 - ITY Assembly, Tube Housing, X-ray, Diagnostic

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