Cleared Traditional

K945496 - MAMMOGRAPHIC X-RAY UNIT

K945496 is an FDA 510(k) clearance for MAMMOGRAPHIC X-RAY UNIT, manufactured by Lorad Corp.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K945496 · Lorad Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
49d
Days
Class 2
Risk

K945496 is an FDA 510(k) clearance for the MAMMOGRAPHIC X-RAY UNIT. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Lorad Corp. (Danbury, US). The FDA issued a Cleared decision on December 27, 1994 after a review of 49 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.

FDA 510(k) Submission Details - K945496

510(k) Number K945496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1994
Decision Date December 27, 1994
Days to Decision 49 days
Submission Type Traditional
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
58d faster than avg
Panel avg: 107d · This submission: 49d
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 151
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K945496.
NOVA XM2
K932356 · Dynarad Corp. · Feb 1995
SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)
K944816 · Philips Medical Systems (Cleveland), Inc. · Feb 1995
ALPHA STEREO
K934478 · Instrumentarium Corp. · Jan 1995
RHODIUM FILTER
K945272 · Lorad Corp. · Dec 1994
BENNETT X-RAY DIGITAL SPOT IMAGER
K935428 · Bennett X-Ray Technologies · Nov 1994
LORAD TRANSPO
K934868 · Lorad Corp. · Oct 1994
K945496 · MAMMOGRAPHIC X-RAY UNIT
Download PDF FDA Summary Lorad Corp.