Cleared Traditional

RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT (K894643) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894643 · Lorad Medical Systems, Inc. · Radiology device
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Dec 1989
Decision
143d
Days
Class 2
Risk

K894643 is an FDA 510(k) clearance for the RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Lorad Medical Systems, Inc. (Danbury, US). The FDA issued a Cleared decision on December 14, 1989 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lorad Medical Systems, Inc. devices

Submission Details

510(k) Number K894643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date December 14, 1989
Days to Decision 143 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 107d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 95
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