Cleared Traditional

K003795 - BIOLUCENT MAMMOGRAPHY CUSHION

K003795 is an FDA 510(k) clearance for BIOLUCENT MAMMOGRAPHY CUSHION, manufactured by Biolucent, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K003795 · Biolucent, Inc. · Radiology device
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Feb 2001
Decision
68d
Days
Class 2
Risk

K003795 is an FDA 510(k) clearance for the BIOLUCENT MAMMOGRAPHY CUSHION. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Biolucent, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on February 14, 2001 after a review of 68 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 Biolucent, Inc. devices

FDA 510(k) Submission Details - K003795

510(k) Number K003795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2000
Decision Date February 14, 2001
Days to Decision 68 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
39d faster than avg
Panel avg: 107d · This submission: 68d
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 97
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K003795.
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
DELTA 32 AND DELTA 32 TACT
K002472 · Instrumentarium Imaging, Inc. · Nov 2000
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
K000976 · Instrumentarium Imaging, Inc. · Jun 2000