Cleared Traditional

K023864 - PERFORMA STEREO

K023864 is an FDA 510(k) clearance for PERFORMA STEREO, manufactured by Instrumentarium Corp. Imaging Division. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K023864 · Instrumentarium Corp. Imaging Division · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
50d
Days
Class 2
Risk

K023864 is an FDA 510(k) clearance for the PERFORMA STEREO. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Instrumentarium Corp. Imaging Division (Milwaukee, US). The FDA issued a Cleared decision on January 9, 2003 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentarium Corp. Imaging Division devices

FDA 510(k) Submission Details - K023864

510(k) Number K023864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2002
Decision Date January 09, 2003
Days to Decision 50 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
57d faster than avg
Panel avg: 107d · This submission: 50d
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 100
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K023864.
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
K040884 · Hologic, Inc. · Apr 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
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K010116 · Planmed OY · Mar 2001
OPDIMA
K003945 · Siemens Medical Solutions USA, Inc. · Feb 2001