Cleared Traditional

K945272 - RHODIUM FILTER

K945272 is an FDA 510(k) clearance for RHODIUM FILTER, manufactured by Lorad Corp.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K945272 · Lorad Corp. · Radiology device
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Dec 1994
Decision
47d
Days
Class 2
Risk

K945272 is an FDA 510(k) clearance for the RHODIUM FILTER. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Lorad Corp. (Danbury, US). The FDA issued a Cleared decision on December 14, 1994 after a review of 47 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 Lorad Corp. devices

FDA 510(k) Submission Details - K945272

510(k) Number K945272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1994
Decision Date December 14, 1994
Days to Decision 47 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 107d · This submission: 47d
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 93
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K945272.
ATHENA HFX
K945619 · Fischer Imaging Corp. · Mar 1995
SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)
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ALPHA STEREO
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MAMMOMAT 300 AND MAMMOMAT 3000
K932672 · Siemens Medical Solutions USA, Inc. · Sep 1994
ADVANCED AUTOMATIC KV
K934831 · Elscint, Inc. · Aug 1994
BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH
K940701 · Bennett X-Ray Corp. · Apr 1994