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FDA 510(k)

RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE

K-Number: K982862 · 1998-10-21

ApplicantApplicare Medical Imaging, B.V.
Decision Date1998-10-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Applicare Medical Imaging, B.V.. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K982862. 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 RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE?

RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Applicare Medical Imaging, B.V.. The 510(k) number is K982862.

When did RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE receive FDA 510(k) clearance?

RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE received FDA 510(k) clearance on 1998-10-21, under 510(k) number K982862.

Who is the listed applicant for RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE?

The FDA 510(k) record lists Applicare Medical Imaging, B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE?

The FDA product code for RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE 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 Applicare Medical Imaging, B.V. 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.

K962699RADWORKS MEDICAL IMAGING SOFTWARE

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

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

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