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FDA 510(k)

CAAS MRV

K-Number: K162112 · 2016-09-21

ApplicantPie Medical Imaging BV
Decision Date2016-09-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAAS MRV is a medical device manufactured by Pie Medical Imaging BV. It received FDA 510(k) clearance on 2016-09-21 under approval number K162112. 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 MRV?

CAAS MRV is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by Pie Medical Imaging BV. The 510(k) number is K162112.

When was CAAS MRV approved by the FDA?

CAAS MRV received FDA 510(k) clearance on 2016-09-21, under approval number K162112.

What company makes CAAS MRV?

CAAS MRV is manufactured by Pie Medical Imaging BV.

What is the FDA product code for CAAS MRV?

The FDA product code for CAAS MRV is LLZ.

Other Devices by Pie Medical Imaging BV

K162376CAAS MR 4D Flow K1537363mensio Workstation K151780CAAS Workstation K181825CAAS MR Solutions K180019CAAS Workstation K212376Caas Qardia

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Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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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