FDA 510(k)

CAAS MRV

K-Number: K162112 · 2016-09-21

Decision Date2016-09-21

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CAAS MRV 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 2016-09-21 under 510(k) 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. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K162112.

When did CAAS MRV receive FDA 510(k) clearance?

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

Who is the listed applicant for CAAS MRV?

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 MRV?

The FDA product code for CAAS MRV 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

View all 10 devices →

Related Devices (Code: LLZ)

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

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.