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FDA 510(k)

IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235

K-Number: K100766 · 2010-07-21

ApplicantIon Beam Applications S.A.
Decision Date2010-07-21
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 is the device name listed in this FDA 510(k) record. The listed applicant is Ion Beam Applications S.A.. It received FDA 510(k) clearance on 2010-07-21 under 510(k) number K100766. 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 IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235?

IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 is a medical device that received FDA 510(k) clearance on 2010-07-21. The listed applicant is Ion Beam Applications S.A.. The 510(k) number is K100766.

When did IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 receive FDA 510(k) clearance?

IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 received FDA 510(k) clearance on 2010-07-21, under 510(k) number K100766.

Who is the listed applicant for IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235?

The FDA 510(k) record lists Ion Beam Applications S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235?

The FDA product code for IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 is LHN.

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Other records listing Ion Beam Applications S.A. 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.

K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)K132847I2CK101508MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235K092796IBA PROTON THERAPY SYSTEM, PROTEUS 235K091629PROTEUS 235 PROTON THERAPY SYSTEMK083058IBA PROTON THERAPY SYSTEM - PROTEUS 235

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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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