Cleared Traditional

K896540 - ACCUSPEC THYROID UPTAKE SYSTEM SOFTWARE (FDA 510(k) Clearance)

Class I Radiology device.

K896540 · Nuclear Data Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
155d
Days
Class 1
Risk

K896540 is an FDA 510(k) clearance for the ACCUSPEC THYROID UPTAKE SYSTEM SOFTWARE. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Nuclear Data Systems (Schaumburg, US). The FDA issued a Cleared decision on April 19, 1990 after a review of 155 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1320 - 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 Nuclear Data Systems devices

Submission Details

510(k) Number K896540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1989
Decision Date April 19, 1990
Days to Decision 155 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 107d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IZD Probe, Uptake, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1320
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.