Cleared Traditional

K020624 - BREAST BOLSTER

K020624 is an FDA 510(k) clearance for BREAST BOLSTER, manufactured by Beekley Corp.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K020624 · Beekley Corp. · Radiology device
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Sep 2002
Decision
198d
Days
Class 2
Risk

K020624 is an FDA 510(k) clearance for the BREAST BOLSTER. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Beekley Corp. (Bristol, US). The FDA issued a Cleared decision on September 12, 2002 after a review of 198 days - an extended review 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: 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 Beekley Corp. devices

FDA 510(k) Submission Details - K020624

510(k) Number K020624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2002
Decision Date September 12, 2002
Days to Decision 198 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 107d · This submission: 198d
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 95
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K020624.
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
K040884 · Hologic, Inc. · Apr 2004
SENOGRAPHIC STEREO
K040125 · Ge Medical Systems, Inc. · Apr 2004
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
K021945 · Planmed OY · Feb 2003
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
K013656 · Planmed OY · Jan 2002
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K010116 · Planmed OY · Mar 2001
OPDIMA
K003945 · Siemens Medical Solutions USA, Inc. · Feb 2001