FDA 510(k)

CAAS

K-Number: K052988 · 2005-12-30

Decision Date2005-12-30

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CAAS 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 2005-12-30 under 510(k) number K052988. 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?

CAAS is a medical device that received FDA 510(k) clearance on 2005-12-30. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K052988.

When did CAAS receive FDA 510(k) clearance?

CAAS received FDA 510(k) clearance on 2005-12-30, under 510(k) number K052988.

Who is the listed applicant for CAAS?

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?

The FDA product code for CAAS is LLZ.

Other records listing Pie Medical Imaging BV 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.

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.