Cleared Traditional

K844120 - ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS (FDA 510(k) Clearance)

Class I Neurology device.

K844120 · Echo Ultrasound · Neurology device
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Jan 1985
Decision
92d
Days
Class 1
Risk

K844120 is an FDA 510(k) clearance for the ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS. Classified as Block, Test, Ultrasonic Scanner Calibration (product code GXX), Class I - General Controls.

Submitted by Echo Ultrasound (Lewistown, US). The FDA issued a Cleared decision on January 23, 1985 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1925 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Echo Ultrasound devices

Submission Details

510(k) Number K844120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date January 23, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 148d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GXX Block, Test, Ultrasonic Scanner Calibration
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1925
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.