Cleared Traditional

K844189 - LINEAR SCANNER PROBE ELSCINT LTD. TL-35

K844189 is an FDA 510(k) clearance for LINEAR SCANNER PROBE ELSCINT LTD. TL-35, manufactured by Elscint, Inc.. The device is a Class 1 Radiology device with product code IYP cleared through the Traditional 510(k) pathway after a 118-day FDA review.

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

FDA 510(k) Submission Details - K844189

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 107d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

IYP Device Classification - Class 1, General Controls

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.