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FDA 510(k)

I2C

K-Number: K132847 · 2013-11-20

ApplicantIon Beam Applications S.A.
Decision Date2013-11-20
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I2C 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 2013-11-20 under 510(k) number K132847. 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 I2C?

I2C is a medical device that received FDA 510(k) clearance on 2013-11-20. The listed applicant is Ion Beam Applications S.A.. The 510(k) number is K132847.

When did I2C receive FDA 510(k) clearance?

I2C received FDA 510(k) clearance on 2013-11-20, under 510(k) number K132847.

Who is the listed applicant for I2C?

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 I2C?

The FDA product code for I2C is LHN.

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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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