Cleared Traditional

K952210 - LORAD STEROLOC II

K952210 is an FDA 510(k) clearance for LORAD STEROLOC II, 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 75-day FDA review.

K952210 · Lorad Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
75d
Days
Class 2
Risk

K952210 is an FDA 510(k) clearance for the LORAD STEROLOC II. 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 July 24, 1995 after a review of 75 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 Lorad Corp. devices

FDA 510(k) Submission Details - K952210

510(k) Number K952210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1995
Decision Date July 24, 1995
Days to Decision 75 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 107d · This submission: 75d
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 93
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K952210.
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
K960381 · Elscint, Inc. · Apr 1996
DELTA 16
K955411 · Instrumentarium Imaging, Inc. · Mar 1996
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250 · GE Medical Systems · Jan 1996
PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT
K951883 · Planmed OY · May 1995
REAL TIME STEREOTIX
K941191 · GE Medical Systems · May 1995
BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI
K944978 · Bennett X-Ray Corp. · May 1995