FDA 510(k)

Geneva

K-Number: K201272 · 2020-07-16

Decision Date2020-07-16

Product CodeJAQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Geneva is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron B.V.. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K201272. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Geneva?

Geneva is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Nucletron B.V.. The 510(k) number is K201272.

When did Geneva receive FDA 510(k) clearance?

Geneva received FDA 510(k) clearance on 2020-07-16, under 510(k) number K201272.

Who is the listed applicant for Geneva?

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

What is the FDA product code for Geneva?

The FDA product code for Geneva is JAQ.

Other records listing Nucletron B.V. 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.

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Related Devices (Code: JAQ)

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical Systems K251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical Systems K250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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.