Cleared Traditional

K932701 - CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS (FDA 510(k) Clearance)

Class I Radiology device.

K932701 · Nuccardiac Software, Inc. · Radiology device
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Mar 1994
Decision
299d
Days
Class 1
Risk

K932701 is an FDA 510(k) clearance for the CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Nuccardiac Software, Inc. (Torba Linda, US). The FDA issued a Cleared decision on March 29, 1994 after a review of 299 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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 Nuccardiac Software, Inc. devices

Submission Details

510(k) Number K932701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1993
Decision Date March 29, 1994
Days to Decision 299 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
192d slower than avg
Panel avg: 107d · This submission: 299d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
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.