Cleared Traditional

K844189 - LINEAR SCANNER PROBE ELSCINT LTD. TL-35 (FDA 510(k) Clearance)

Class I Radiology device.

K844189 · Elscint, Inc. · Radiology device
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Feb 1985
Decision
118d
Days
Class 1
Risk

K844189 is an FDA 510(k) clearance for the LINEAR SCANNER PROBE ELSCINT LTD. TL-35. Classified as Phantom, Anthropomorphic, Nuclear (product code IYP), Class I - General Controls.

Submitted by Elscint, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on February 25, 1985 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1370 - 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 Elscint, Inc. devices

Submission Details

510(k) Number K844189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1984
Decision Date February 25, 1985
Days to Decision 118 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 107d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYP Phantom, Anthropomorphic, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1370
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.