Cleared Special

K013290 - MODIFIED 650 MAMMOGRAPHY SYSTEM

K013290 is an FDA 510(k) clearance for MODIFIED 650 MAMMOGRAPHY SYSTEM, 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 22-day FDA review.

K013290 · Lorad, A Hologic Co. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
22d
Days
Class 2
Risk

K013290 is an FDA 510(k) clearance for the MODIFIED 650 MAMMOGRAPHY SYSTEM. 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 October 24, 2001 after a review of 22 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 - K013290

510(k) Number K013290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2001
Decision Date October 24, 2001
Days to Decision 22 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
85d faster than avg
Panel avg: 107d · This submission: 22d
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 K013290.
DELTA 32
K022275 · Instrumentarium Corp. Imaging Division · Sep 2002
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
K013656 · Planmed OY · Jan 2002
GIOTTO IMAGE
K012953 · Medx, Inc. · Nov 2001
MODIFIED M-IV MAMMOGRAPHY SYSTEM
K011987 · Lorad, A Hologic Co. · Jul 2001
MAMMOGRAPH
K010792 · Digitec Medical Service Corp. · Apr 2001
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K010116 · Planmed OY · Mar 2001
K013290 · MODIFIED 650 MAMMOGRAPHY SYSTEM
Download PDF FDA Summary Lorad, A Hologic Co.