FDA 510(k)

CAAS II QVA

K-Number: K012475 · 2001-10-24

Decision Date2001-10-24

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CAAS II QVA 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 2001-10-24 under 510(k) number K012475. 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 II QVA?

CAAS II QVA is a medical device that received FDA 510(k) clearance on 2001-10-24. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K012475.

When did CAAS II QVA receive FDA 510(k) clearance?

CAAS II QVA received FDA 510(k) clearance on 2001-10-24, under 510(k) number K012475.

Who is the listed applicant for CAAS II QVA?

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 II QVA?

The FDA product code for CAAS II QVA is LLZ.

Other records listing Pie Medical Imaging BV as applicant

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K2503303mensio Workstation K232147CAAS Workstation K232007CAAS MR Solutions K212376Caas Qardia K181825CAAS MR Solutions K180019CAAS Workstation

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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.