Cleared Traditional

K921878 - SCANMATE III

K921878 is an FDA 510(k) clearance for SCANMATE III, manufactured by Circadian, Inc.. The device is a Class 1 Radiology device with product code IYP cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K921878 · Circadian, Inc. · Radiology device
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Sep 1992
Decision
144d
Days
Class 1
Risk

K921878 is an FDA 510(k) clearance for the SCANMATE III. Classified as Phantom, Anthropomorphic, Nuclear (product code IYP), Class I - General Controls.

Submitted by Circadian, Inc. (San Leandro, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1370 - 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 Circadian, Inc. devices

FDA 510(k) Submission Details - K921878

510(k) Number K921878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1992
Decision Date September 11, 1992
Days to Decision 144 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 107d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

IYP Device Classification - Class 1, General Controls

Product Code IYP Phantom, Anthropomorphic, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1370
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.