Cleared Traditional

K893216 - RMI ULTRASOUND DOPPLER PHANTOM SYSTEM (FDA 510(k) Clearance)

Class I Neurology device.

K893216 · Radiation Measurements, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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.