Cleared Traditional

K834285 - KC 100 M

K834285 is the FDA 510(k) clearance for KC 100 M by Elscint, Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K834285 · Elscint, Inc. · Radiology device
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Feb 1984
Decision
94d
Days
Class 2
Risk

K834285 is an FDA 510(k) clearance for the KC 100 M. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Elscint, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1984 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 K834285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1983
Decision Date February 17, 1984
Days to Decision 94 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
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

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