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FDA 510(k)

IPLAN RT DOSE

K-Number: K053584 · 2006-07-12

ApplicantBrainlab AG
Decision Date2006-07-12
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IPLAN RT DOSE is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2006-07-12 under 510(k) number K053584. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPLAN RT DOSE?

IPLAN RT DOSE is a medical device that received FDA 510(k) clearance on 2006-07-12. The listed applicant is Brainlab AG. The 510(k) number is K053584.

When did IPLAN RT DOSE receive FDA 510(k) clearance?

IPLAN RT DOSE received FDA 510(k) clearance on 2006-07-12, under 510(k) number K053584.

Who is the listed applicant for IPLAN RT DOSE?

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

What is the FDA product code for IPLAN RT DOSE?

The FDA product code for IPLAN RT DOSE is MUJ.

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Other records listing Brainlab AG 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: MUJ)

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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