FDA 510(k)

Segment CMR

K-Number: K163076 · 2017-04-05

Decision Date2017-04-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Segment CMR is the device name listed in this FDA 510(k) record. The listed applicant is Medviso AB. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K163076. 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 Segment CMR?

Segment CMR is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is Medviso AB. The 510(k) number is K163076.

When did Segment CMR receive FDA 510(k) clearance?

Segment CMR received FDA 510(k) clearance on 2017-04-05, under 510(k) number K163076.

Who is the listed applicant for Segment CMR?

The FDA 510(k) record lists Medviso AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Segment CMR?

The FDA product code for Segment CMR is LLZ.

Other records listing Medviso AB 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.

K211966Segment 3DPrint

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.