FDA 510(k)

CAAS QCA 3D

K-Number: K063344 · 2006-11-28

Decision Date2006-11-28

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CAAS QCA 3D is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Imaging BV. It received FDA 510(k) clearance on 2006-11-28 under 510(k) number K063344. 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 CAAS QCA 3D?

CAAS QCA 3D is a medical device that received FDA 510(k) clearance on 2006-11-28. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K063344.

When did CAAS QCA 3D receive FDA 510(k) clearance?

CAAS QCA 3D received FDA 510(k) clearance on 2006-11-28, under 510(k) number K063344.

Who is the listed applicant for CAAS QCA 3D?

The FDA 510(k) record lists Pie Medical Imaging BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAAS QCA 3D?

The FDA product code for CAAS QCA 3D is LLZ.

Other records listing Pie Medical Imaging BV as applicant

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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.