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FDA 510(k)

AYCAN WORKSTATION OSIRIX PRO

K-Number: K103546 · 2011-03-17

ApplicantAycan Digitalsysteme GmbH
Decision Date2011-03-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AYCAN WORKSTATION OSIRIX PRO is the device name listed in this FDA 510(k) record. The listed applicant is Aycan Digitalsysteme GmbH. It received FDA 510(k) clearance on 2011-03-17 under 510(k) number K103546. 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 AYCAN WORKSTATION OSIRIX PRO?

AYCAN WORKSTATION OSIRIX PRO is a medical device that received FDA 510(k) clearance on 2011-03-17. The listed applicant is Aycan Digitalsysteme GmbH. The 510(k) number is K103546.

When did AYCAN WORKSTATION OSIRIX PRO receive FDA 510(k) clearance?

AYCAN WORKSTATION OSIRIX PRO received FDA 510(k) clearance on 2011-03-17, under 510(k) number K103546.

Who is the listed applicant for AYCAN WORKSTATION OSIRIX PRO?

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

What is the FDA product code for AYCAN WORKSTATION OSIRIX PRO?

The FDA product code for AYCAN WORKSTATION OSIRIX PRO is LLZ.

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 Aycan Digitalsysteme GmbH 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.

K122260AYCAN MOBILEK063470AYCAN WORKSTATION OSIRIX

Related Devices (Code: LLZ)

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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