Cleared Traditional

K841440 - ND62T THYROID UPTAKE SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K841440 · Nuclear Data, Inc. · Radiology device
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Jun 1984
Decision
60d
Days
Class 1
Risk

K841440 is an FDA 510(k) clearance for the ND62T THYROID UPTAKE SYSTEM. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Nuclear Data, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 5, 1984 after a review of 60 days - a notably fast clearance 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: 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 Nuclear Data, Inc. devices

Submission Details

510(k) Number K841440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1984
Decision Date June 05, 1984
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
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.