Cleared Traditional

K920731 - X-RAY TUBE ASSEMBLY CIRCLEX1.2UG

K920731 is the FDA 510(k) clearance for X-RAY TUBE ASSEMBLY CIRCLEX1.2UG by Shimadzu Medical Systems. It is a Class 1 Radiology device (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

Submission Details

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.

Device Classification

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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