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)

RADIONICS XKNIFE HDRT SYSTEM

K-Number: K083414 · 2009-03-02

ApplicantIntegra Radionics, Inc.
Decision Date2009-03-02
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIONICS XKNIFE HDRT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integra Radionics, Inc.. It received FDA 510(k) clearance on 2009-03-02 under 510(k) number K083414. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIONICS XKNIFE HDRT SYSTEM?

RADIONICS XKNIFE HDRT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-03-02. The listed applicant is Integra Radionics, Inc.. The 510(k) number is K083414.

When did RADIONICS XKNIFE HDRT SYSTEM receive FDA 510(k) clearance?

RADIONICS XKNIFE HDRT SYSTEM received FDA 510(k) clearance on 2009-03-02, under 510(k) number K083414.

Who is the listed applicant for RADIONICS XKNIFE HDRT SYSTEM?

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

What is the FDA product code for RADIONICS XKNIFE HDRT SYSTEM?

The FDA product code for RADIONICS XKNIFE HDRT SYSTEM is MUJ.

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 Integra Radionics, 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.

K102258CUSA NXT EXTENDED LENGTH TIPK100096LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHARTK100417XKNIFE 5K090864CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMK081459CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEMK072454INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS

View all 10 devices →

Related Devices (Code: MUJ)

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.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.

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.

↑