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FDA 510(k)

INTRAOPERATIVE RADIATION THERAPY DEVICES

K-Number: K891261 · 1989-04-26

ApplicantGeneral Electric Co.
Decision Date1989-04-26
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTRAOPERATIVE RADIATION THERAPY DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1989-04-26 under 510(k) number K891261. 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 INTRAOPERATIVE RADIATION THERAPY DEVICES?

INTRAOPERATIVE RADIATION THERAPY DEVICES is a medical device that received FDA 510(k) clearance on 1989-04-26. The listed applicant is General Electric Co.. The 510(k) number is K891261.

When did INTRAOPERATIVE RADIATION THERAPY DEVICES receive FDA 510(k) clearance?

INTRAOPERATIVE RADIATION THERAPY DEVICES received FDA 510(k) clearance on 1989-04-26, under 510(k) number K891261.

Who is the listed applicant for INTRAOPERATIVE RADIATION THERAPY DEVICES?

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

What is the FDA product code for INTRAOPERATIVE RADIATION THERAPY DEVICES?

The FDA product code for INTRAOPERATIVE RADIATION THERAPY DEVICES is LHN.

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Other records listing General Electric Co. as applicant

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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

View on FDA Database →

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

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