Cedars-Sinai Quantitative TI-201 Analysis CTQ 2.0

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K905222 ↗

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

• Ctq - Cedars-Sinai Quantitative Thallium-201 Analy

  Class II

  FDA 510(k) K882271 Active Cleared 3 Nov 1988

• Cequal-Quantitative Analysis

  Class II

  FDA 510(k) K942363 Active Cleared 16 Sep 1994

• 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 Cedars-Sinai Quantitative Ti-201 Analysis CTQ 2.0 used for?

  This software is designed for quantitative analysis of myocardial perfusion imaging data obtained through single-photon emission computed tomography (SPECT) using thallium-201 (Ti-201). It evaluates radiotracer distribution to help diagnose and assess coronary artery disease and myocardial ischemia by providing objective measurements of blood flow and perfusion in the heart muscle.

• How is the Cedars-Sinai Quantitative Ti-201 Analysis CTQ 2.0 supplied and installed?

  The CTQ 2.0 is supplied as a digital product and requires installation on compatible hardware systems, such as Medasys Digital Systems. It is not a physical device but rather a standalone analysis tool meant to integrate with existing radiology imaging workflows. Installation instructions would typically involve IT system setup and configuration, following manufacturer guidelines.

• Is the Cedars-Sinai Quantitative Ti-201 Analysis CTQ 2.0 single-use or reusable?

  The CTQ 2.0 is not classified as single-use or reusable in the traditional sense, as it is a software system intended for repeated use in clinical settings. It operates on digital hardware and can be utilized across multiple patient studies, provided the system remains properly maintained and updated according to manufacturer recommendations.

• Are there any sterility or MRI safety requirements for the Cedars-Sinai Quantitative Ti-201 Analysis CTQ 2.0?

  The regulatory filing for this device does not specify any sterility requirements, as it is a software-based system and not a physical medical device requiring sterilization. Additionally, there are no explicit MRI safety requirements noted, as the software itself does not interact with MRI environments or equipment. Standard IT system maintenance practices apply.

• What hardware compatibility does the Cedars-Sinai Quantitative Ti-201 Analysis CTQ 2.0 require?

  The CTQ 2.0 is intended for use on compatible digital imaging systems, specifically mentioned as Medasys Digital Systems in the manufacturer’s documentation. The software is not hardware-specific beyond this compatibility requirement, so users should verify their existing imaging infrastructure meets the necessary technical specifications outlined by Nuccardiac Software, Inc.