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)

IQQA-LIVER SOFTWARE

K-Number: K061696 · 2006-11-13

ApplicantEdda Technology, Inc.
Decision Date2006-11-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IQQA-LIVER SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Edda Technology, Inc.. It received FDA 510(k) clearance on 2006-11-13 under 510(k) number K061696. 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 IQQA-LIVER SOFTWARE?

IQQA-LIVER SOFTWARE is a medical device that received FDA 510(k) clearance on 2006-11-13. The listed applicant is Edda Technology, Inc.. The 510(k) number is K061696.

When did IQQA-LIVER SOFTWARE receive FDA 510(k) clearance?

IQQA-LIVER SOFTWARE received FDA 510(k) clearance on 2006-11-13, under 510(k) number K061696.

Who is the listed applicant for IQQA-LIVER SOFTWARE?

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

What is the FDA product code for IQQA-LIVER SOFTWARE?

The FDA product code for IQQA-LIVER SOFTWARE 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 Edda Technology, 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.

K131498IQQA-LIVER MULTIMODALITY SOFTWAREK042408IQQA-CHEST SOFTWARE PACKAGE

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.

↑