Cleared Special

K030666 - MULTICARE PLATINUM SYSTEM AND ACCESSORIES

K030666 is an FDA 510(k) clearance for MULTICARE PLATINUM SYSTEM AND ACCESSORIES, 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.

K030666 · Lorad, A Hologic Co. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
22d
Days
Class 2
Risk

K030666 is an FDA 510(k) clearance for the MULTICARE PLATINUM SYSTEM AND ACCESSORIES. 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 March 25, 2003 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 - K030666

510(k) Number K030666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2003
Decision Date March 25, 2003
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 K030666.
SENOGRAPHIC STEREO
K040125 · Ge Medical Systems, Inc. · Apr 2004
ADVANTAGE PADDLE
K033202 · Livingston Products, Inc. · Dec 2003
SQUEEZE-EASE MAMMOGRAPHY CUSHION
K031574 · S & S X-Ray Products, Inc. · Aug 2003
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
K021945 · Planmed OY · Feb 2003
PERFORMA STEREO
K023864 · Instrumentarium Corp. Imaging Division · Jan 2003
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
K023229 · American Mammographics, Inc. · Dec 2002
K030666 · MULTICARE PLATINUM SYSTEM AND ACCESSORIES
Download PDF FDA Summary Lorad, A Hologic Co.