Cleared Traditional

K893216 - RMI ULTRASOUND DOPPLER PHANTOM SYSTEM

K893216 is an FDA 510(k) clearance for RMI ULTRASOUND DOPPLER PHANTOM SYSTEM, manufactured by Radiation Measurements, Inc.. The device is a Class 1 Neurology device with product code GXX cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K893216 · Radiation Measurements, Inc. · Neurology device
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Sep 1989
Decision
131d
Days
Class 1
Risk

K893216 is an FDA 510(k) clearance for the RMI ULTRASOUND DOPPLER PHANTOM SYSTEM. Classified as Block, Test, Ultrasonic Scanner Calibration (product code GXX), Class I - General Controls.

Submitted by Radiation Measurements, Inc. (Middleton, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 131 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 Radiation Measurements, Inc. devices

FDA 510(k) Submission Details - K893216

510(k) Number K893216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1989
Decision Date September 05, 1989
Days to Decision 131 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 148d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

GXX Device Classification - Class 1, General Controls

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.