Cleared Traditional

K834607 - ELECTRONIC KVP CASSETTE (FDA 510(k) Clearance)

Class I Radiology device.

K834607 · Radiation Measurements, Inc. · Radiology device
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Feb 1984
Decision
67d
Days
Class 1
Risk

K834607 is an FDA 510(k) clearance for the ELECTRONIC KVP CASSETTE. Classified as Cassette, Measurement, Ardran-crooks (product code IWN), Class I - General Controls.

Submitted by Radiation Measurements, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1940 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Radiation Measurements, Inc. devices

Submission Details

510(k) Number K834607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1983
Decision Date February 21, 1984
Days to Decision 67 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 107d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWN Cassette, Measurement, Ardran-crooks
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1940
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.