Cleared Traditional

K910842 - DI2000/HS-45-150 X-RAY TUBE INSERT

K910842 is an FDA 510(k) clearance for DI2000/HS-45-150 X-RAY TUBE INSERT, manufactured by Comet Ltd. C/O Radiology Resources, Inc.. The device is a Class 1 Radiology device with product code ITY cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K910842 · Comet Ltd. C/O Radiology Resources, Inc. · Radiology device
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Mar 1991
Decision
7d
Days
Class 1
Risk

K910842 is an FDA 510(k) clearance for the DI2000/HS-45-150 X-RAY TUBE INSERT. Classified as Assembly, Tube Housing, X-ray, Diagnostic (product code ITY), Class I - General Controls.

Submitted by Comet Ltd. C/O Radiology Resources, Inc. (Switzerland, CH). The FDA issued a Cleared decision on March 6, 1991 after a review of 7 days - a notably fast clearance cycle.

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: 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 Comet Ltd. C/O Radiology Resources, Inc. devices

FDA 510(k) Submission Details - K910842

510(k) Number K910842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1991
Decision Date March 06, 1991
Days to Decision 7 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 107d · This submission: 7d
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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