Ctq - Cedars-Sinai Quantitative Thallium-201 Analy

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K882271 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Clinical Diagnostic Software

  Class II

  FDA 510(k) K970288 Active Cleared 24 Apr 1997

• Cequal(Tm) Quanitative Analysis Cardiolite(R) Spec

  Class II

  FDA 510(k) K914296 Active Cleared 27 Nov 1991

• Cequal-Quantitative Analysis

  Class II

  FDA 510(k) K942363 Active Cleared 16 Sep 1994

• Cedars-Sinai Quantitative TI-201 Analysis CTQ 2.0

  Class II

  FDA 510(k) K905222 Active Cleared 26 Dec 1990

• Modified Cedars-Sinai Quanti Thallium-201 Analysis

  Class II

  FDA 510(k) K892397 Active Cleared 27 Oct 1989

• Cequal-Quantitative Analysis for Cardiolite Executing on the Medasys Digital Systems Computer

  Class II

  FDA 510(k) K972509 Active Cleared 8 Sep 1997

See all devices from Nuccardiac Software, Inc. →

• What is the CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY used for?

  This software device is designed for quantitative analysis of Thallium-201 in medical imaging studies. It processes and analyzes Thallium-201 imaging data to provide quantitative measurements that assist in diagnostic procedures within radiology settings.

• How is the CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY supplied?

  The device is supplied as software manufactured by Nuccardiac Software, Inc. The provided data does not specify whether it is single-use or reusable, indicating it is a software solution that can be implemented in appropriate medical imaging systems.

• What is the regulatory status of the CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY?

  This device has received FDA 510(k) clearance with product code LLZ and is classified as a Class II device. It was determined to be substantially equivalent through the traditional clearance process, with the review handled by the Radiology advisory committee.

• What are the specifications of the CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY?

  The device is a software solution for quantitative analysis of Thallium-201 imaging data. It was cleared by the FDA in 1988 (K882271) and is manufactured by Nuccardiac Software, Inc. located in Torba Linda, CA. The device is intended for use in radiology departments for diagnostic purposes.