Cleared Traditional

K834496 - ISOREX LS-36

K834496 is the FDA 510(k) clearance for ISOREX LS-36 by Elscint, Inc.. It is a Class 2 Radiology device (product code IZI) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K834496 · Elscint, Inc. · Radiology device
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Feb 1984
Decision
75d
Days
Class 2
Risk

K834496 is an FDA 510(k) clearance for the ISOREX LS-36. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Elscint, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 Elscint, Inc. devices

Submission Details

510(k) Number K834496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1983
Decision Date February 21, 1984
Days to Decision 75 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 101
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