Cleared Traditional

K920727 - CEILING TUBE SUPPORT CH-30X

K920727 is an FDA 510(k) clearance for CEILING TUBE SUPPORT CH-30X, manufactured by Shimadzu Medical Systems. The device is a Class 1 Radiology device with product code IYB cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K920727 · Shimadzu Medical Systems · Radiology device
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Apr 1992
Decision
58d
Days
Class 1
Risk

K920727 is an FDA 510(k) clearance for the CEILING TUBE SUPPORT CH-30X. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on April 16, 1992 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1770 - 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 Shimadzu Medical Systems devices

FDA 510(k) Submission Details - K920727

510(k) Number K920727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1992
Decision Date April 16, 1992
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

IYB Device Classification - Class 1, General Controls

Product Code IYB Tube Mount, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1770
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 - IYB Tube Mount, X-ray, Diagnostic

All 20
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