Cleared Special

K040884 - LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM

K040884 is an FDA 510(k) clearance for LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM, manufactured by Hologic, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Special 510(k) pathway after a 18-day FDA review.

K040884 · Hologic, Inc. · Radiology device
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Apr 2004
Decision
18d
Days
Class 2
Risk

K040884 is an FDA 510(k) clearance for the LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Hologic, Inc. (Danbury, US). The FDA issued a Cleared decision on April 23, 2004 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hologic, Inc. devices

FDA 510(k) Submission Details - K040884

510(k) Number K040884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2004
Decision Date April 23, 2004
Days to Decision 18 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 107d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 109
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K040884.
TRAXYLOC-1 SYSTEM
K050663 · Traxyz Medical, Inc. · Apr 2005
PLANMED SOPHIE NUANCE CLASSIC
K042671 · Planmed OY · Nov 2004
MAMMOTEST
K042095 · Fischer Imaging Corp. · Oct 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