Cleared Traditional

K882271 - CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY

K882271 is an FDA 510(k) clearance for CTQ - CEDARS-SINAI QUANTITATIVE THALLIU..., manufactured by Nuccardiac Software, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K882271 · Nuccardiac Software, Inc. · Radiology device
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Nov 1988
Decision
156d
Days
Class 2
Risk

K882271 is an FDA 510(k) clearance for the CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Nuccardiac Software, Inc. (Torba Linda, US). The FDA issued a Cleared decision on November 3, 1988 after a review of 156 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Nuccardiac Software, Inc. devices

FDA 510(k) Submission Details - K882271

510(k) Number K882271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date November 03, 1988
Days to Decision 156 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 107d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1713
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K882271.
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DIGITRON STENOSIS PROTOCOL
K881481 · Siemens Gammasonics, Inc. · Oct 1988
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VIEWPOINT
K882205 · Adac Laboratories · Aug 1988