Cleared Traditional

4200 ME ECHOENCEPHALOGRAPH (K800101) - FDA 510(k) Clearance

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

K800101 · Kt Medical, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1980
Decision
109d
Days
Class 2
Risk

K800101 is an FDA 510(k) clearance for the 4200 ME ECHOENCEPHALOGRAPH. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Kt Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1980 after a review of 109 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 Kt Medical, Inc. devices

Submission Details

510(k) Number K800101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1980
Decision Date May 02, 1980
Days to Decision 109 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 107d · This submission: 109d
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

All 213
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K800101.
DATASON DB SYSTEM
K801986 · General Electric Co. · Nov 1980
MINIVISOR TERMINAL
K802263 · Organon Teknika Corp. · Oct 1980
DATASON RTL
K801454 · General Electric Co. · Sep 1980
SMV 120 SONIC MAMMOGRAPHIC VIEWER
K792585 · Johnson & Johnson Professionals, Inc. · Jan 1980
DATASON-GS
K791755 · General Electric Co. · Oct 1979
MODEL 1338A CRT DISPLAY
K791343 · Hewlett-Packard Co. · Sep 1979