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FDA 510(k)

RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM

K-Number: K860606 · 1986-03-20

ApplicantBionix Corp.
Decision Date1986-03-20
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Corp.. It received FDA 510(k) clearance on 1986-03-20 under 510(k) number K860606. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM?

RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1986-03-20. The listed applicant is Bionix Corp.. The 510(k) number is K860606.

When did RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM receive FDA 510(k) clearance?

RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM received FDA 510(k) clearance on 1986-03-20, under 510(k) number K860606.

Who is the listed applicant for RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM?

The FDA 510(k) record lists Bionix Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM?

The FDA product code for RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM is LHN.

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.

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Other records listing Bionix Corp. 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.

K852039FLEX-LOOP FLEXIBLE EAR CORETTE

Related Devices (Code: LHN)

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.

K260597VIRTUE QAProNova SolutionsK260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, 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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