Cleared Traditional

K073262 - BELLA

K073262 is an FDA 510(k) clearance for BELLA, 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 127-day FDA review.

K073262 · Beekley Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
127d
Days
Class 2
Risk

K073262 is an FDA 510(k) clearance for the BELLA. 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 March 26, 2008 after a review of 127 days - within the typical 510(k) review window.

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 - K073262

510(k) Number K073262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2007
Decision Date March 26, 2008
Days to Decision 127 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
20d slower than avg
Panel avg: 107d · This submission: 127d
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 K073262.
Affirm Prone Biopsy System
K153486 · Hologic, Inc. · Apr 2016
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K103512 · Hologic, Inc. · Jan 2011
DIGITAL SPOT MAMMOGRAPHY SYSTEM
K100692 · Hologic, Inc. · Apr 2010
PLANMED SOPHIE NUANCE CLASSIC
K042671 · Planmed OY · Nov 2004
MAMMOTEST
K042095 · Fischer Imaging Corp. · Oct 2004
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
K040884 · Hologic, Inc. · Apr 2004