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FDA 510(k)

CENTRION 500 C-ARM SYSTEM

K-Number: K050866 · 2005-04-27

ApplicantOsteosys Co.,Ltd
Decision Date2005-04-27
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CENTRION 500 C-ARM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteosys Co.,Ltd. It received FDA 510(k) clearance on 2005-04-27 under 510(k) number K050866. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRION 500 C-ARM SYSTEM?

CENTRION 500 C-ARM SYSTEM is a medical device that received FDA 510(k) clearance on 2005-04-27. The listed applicant is Osteosys Co.,Ltd. The 510(k) number is K050866.

When did CENTRION 500 C-ARM SYSTEM receive FDA 510(k) clearance?

CENTRION 500 C-ARM SYSTEM received FDA 510(k) clearance on 2005-04-27, under 510(k) number K050866.

Who is the listed applicant for CENTRION 500 C-ARM SYSTEM?

The FDA 510(k) record lists Osteosys Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTRION 500 C-ARM SYSTEM?

The FDA product code for CENTRION 500 C-ARM SYSTEM is JAA.

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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.

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