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FDA 510(k)

OSIRIX MD

K-Number: K101342 · 2010-08-20

ApplicantPixmeo Sarl
Decision Date2010-08-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OSIRIX MD is the device name listed in this FDA 510(k) record. The listed applicant is Pixmeo Sarl. It received FDA 510(k) clearance on 2010-08-20 under 510(k) number K101342. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSIRIX MD?

OSIRIX MD is a medical device that received FDA 510(k) clearance on 2010-08-20. The listed applicant is Pixmeo Sarl. The 510(k) number is K101342.

When did OSIRIX MD receive FDA 510(k) clearance?

OSIRIX MD received FDA 510(k) clearance on 2010-08-20, under 510(k) number K101342.

Who is the listed applicant for OSIRIX MD?

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

What is the FDA product code for OSIRIX MD?

The FDA product code for OSIRIX MD is LLZ.

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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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