Cleared Traditional

K901997 - X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS

K901997 is an FDA 510(k) clearance for X-RAY TUBE HOUSING ASSEMBLY, manufactured by Comet Ltd. C/O Radiology Resources, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K901997 · Comet Ltd. C/O Radiology Resources, Inc. · Radiology device
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Jun 1990
Decision
35d
Days
Class 2
Risk

K901997 is an FDA 510(k) clearance for the X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Comet Ltd. C/O Radiology Resources, Inc. (Switzerland, CH). The FDA issued a Cleared decision on June 6, 1990 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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 - K901997

510(k) Number K901997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1990
Decision Date June 06, 1990
Days to Decision 35 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZH Device Classification - Class 2, Special Controls

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZH System, X-ray, Mammographic

All 111
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K901997.
VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS
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K900989 · Fischer Imaging Corp. · Mar 1990
CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC
K896609 · Philips Medical Systems North America, Inc. · Jan 1990
STEREOTACTIC BIOPSY ATTACHMENT
K884107 · Siemens Medical Solutions USA, Inc. · May 1989