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FDA 510(k)

FLEXITRON

K-Number: K070574 · 2007-04-13

ApplicantIsodose Control B.V.
Decision Date2007-04-13
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLEXITRON is the device name listed in this FDA 510(k) record. The listed applicant is Isodose Control B.V.. It received FDA 510(k) clearance on 2007-04-13 under 510(k) number K070574. 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 FLEXITRON?

FLEXITRON is a medical device that received FDA 510(k) clearance on 2007-04-13. The listed applicant is Isodose Control B.V.. The 510(k) number is K070574.

When did FLEXITRON receive FDA 510(k) clearance?

FLEXITRON received FDA 510(k) clearance on 2007-04-13, under 510(k) number K070574.

Who is the listed applicant for FLEXITRON?

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

What is the FDA product code for FLEXITRON?

The FDA product code for FLEXITRON is JAQ.

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 Isodose Control 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.

K091145FLEXIPLAN 3D AND 3D+K082530APPLICATORS FOR AFTERLOADING BRACHYTHERAPYK081112FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM

Related Devices (Code: JAQ)

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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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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