Cleared Traditional

K932153 - THYROID UPTAKE SYSTEM & ATOMLAB 950 MED...

K932153 is an FDA 510(k) clearance for THYROID UPTAKE SYSTEM & ATOMLAB 950 MED..., manufactured by Biodan Medical Systems, Ltd.. The device is a Class 1 Radiology device with product code IZD cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K932153 · Biodan Medical Systems, Ltd. · Radiology device
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Sep 1993
Decision
126d
Days
Class 1
Risk

K932153 is an FDA 510(k) clearance for the THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on September 7, 1993 after a review of 126 days - within the typical 510(k) review window.

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 Biodan Medical Systems, Ltd. devices

FDA 510(k) Submission Details - K932153

510(k) Number K932153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1993
Decision Date September 07, 1993
Days to Decision 126 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
19d slower than avg
Panel avg: 107d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

IZD Device Classification - Class 1, General Controls

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.