Cleared Traditional

K911563 - INVENTOR RT/EXPLORER TRAUMA UNIT

K911563 is an FDA 510(k) clearance for INVENTOR RT/EXPLORER TRAUMA UNIT, manufactured by Continental X-Ray Corp.. The device is a Class 1 Radiology device with product code IYB cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K911563 · Continental X-Ray Corp. · Radiology device
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Oct 1991
Decision
198d
Days
Class 1
Risk

K911563 is an FDA 510(k) clearance for the INVENTOR RT/EXPLORER TRAUMA UNIT. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Continental X-Ray Corp. (Broadview, US). The FDA issued a Cleared decision on October 23, 1991 after a review of 198 days - an extended review 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: 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 Continental X-Ray Corp. devices

FDA 510(k) Submission Details - K911563

510(k) Number K911563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1991
Decision Date October 23, 1991
Days to Decision 198 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 107d · This submission: 198d
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 13
Devices cleared under the same product code (IYB) and FDA review panel - the closest regulatory comparables to K911563.
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K893652 · Fischer Imaging Corp. · Jun 1989