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FDA 510(k)

RADWORKS MEDICAL IMAGING SOFTWARE

K-Number: K962699 · 1996-08-19

ApplicantApplicare Medical Imaging, B.V.
Decision Date1996-08-19
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADWORKS MEDICAL IMAGING SOFTWARE 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 1996-08-19 under 510(k) number K962699. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADWORKS MEDICAL IMAGING SOFTWARE?

RADWORKS MEDICAL IMAGING SOFTWARE is a medical device that received FDA 510(k) clearance on 1996-08-19. The listed applicant is Applicare Medical Imaging, B.V.. The 510(k) number is K962699.

When did RADWORKS MEDICAL IMAGING SOFTWARE receive FDA 510(k) clearance?

RADWORKS MEDICAL IMAGING SOFTWARE received FDA 510(k) clearance on 1996-08-19, under 510(k) number K962699.

Who is the listed applicant for RADWORKS MEDICAL IMAGING SOFTWARE?

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?

The FDA product code for RADWORKS MEDICAL IMAGING SOFTWARE is LMD.

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.

K982862RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE

Related Devices (Code: LMD)

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.

K994329IIVS INTEGRATED IMAGE VIEWING STATIONTerarecon,Inc.K992698STENTOR, PAGEVIEWStentor, Inc.K992426RAYPAX WEB CLINICAL SYSTEMSamsung Sds Co., Ltd.K992352ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0Inteleradiology, Inc.K991537SAMSUNG RAYPAX SYSTEMSamsung Sds Co., Ltd.K984000STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEMSurgical Navigation Technologies, Inc.

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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