Cleared Special

K071542 - DIGITAL STEREOLOC II

K071542 is an FDA 510(k) clearance for DIGITAL STEREOLOC II, manufactured by Lorad, A Hologic Co.. The device is a Class 2 Radiology device with product code IZH cleared through the Special 510(k) pathway after a 30-day FDA review.

K071542 · Lorad, A Hologic Co. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
30d
Days
Class 2
Risk

K071542 is an FDA 510(k) clearance for the DIGITAL STEREOLOC II. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Lorad, A Hologic Co. (Danbury, US). The FDA issued a Cleared decision on July 5, 2007 after a review of 30 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.

FDA 510(k) Submission Details - K071542

510(k) Number K071542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2007
Decision Date July 05, 2007
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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 151
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K071542.
DIGITAL SPOT MAMMOGRAPHY SYSTEM
K100692 · Hologic, Inc. · Apr 2010
BELLA
K073262 · Beekley Corp. · Mar 2008
BEMITT, MODEL 0001
K071787 · Dja Distributors, LLC · Oct 2007
LIV BREAST SELF EXAMINATION AID
K070344 · Liv International USA, Inc. · Mar 2007
BIOPSY DIGIT-AM
K062039 · Giotto USA, LLC · Sep 2006
TRAXYLOC-1 SYSTEM
K050663 · Traxyz Medical, Inc. · Apr 2005
K071542 · DIGITAL STEREOLOC II
Download PDF FDA Summary Lorad, A Hologic Co.