Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS

K-Number: K892397 · 1989-10-27

ApplicantNuccardiac Software, Inc.
Decision Date1989-10-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Nuccardiac Software, Inc.. It received FDA 510(k) clearance on 1989-10-27 under 510(k) number K892397. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS?

MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS is a medical device that received FDA 510(k) clearance on 1989-10-27. The listed applicant is Nuccardiac Software, Inc.. The 510(k) number is K892397.

When did MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS receive FDA 510(k) clearance?

MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS received FDA 510(k) clearance on 1989-10-27, under 510(k) number K892397.

Who is the listed applicant for MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS?

The FDA 510(k) record lists Nuccardiac Software, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS?

The FDA product code for MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS is LLZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Nuccardiac Software, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972509CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTERK970288CLINICAL DIAGNOSTIC SOFTWAREK944720COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTIONK942363CEQUAL-QUANTITATIVE ANALYSISK932701CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSISK922671CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSIS

View all 12 devices →

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑