FDA 510(k)

cNeuro cMRI

K-Number: K171328 · 2018-01-08

Decision Date2018-01-08

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

cNeuro cMRI is the device name listed in this FDA 510(k) record. The listed applicant is Combinostics OY. It received FDA 510(k) clearance on 2018-01-08 under 510(k) number K171328. 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 cNeuro cMRI?

cNeuro cMRI is a medical device that received FDA 510(k) clearance on 2018-01-08. The listed applicant is Combinostics OY. The 510(k) number is K171328.

When did cNeuro cMRI receive FDA 510(k) clearance?

cNeuro cMRI received FDA 510(k) clearance on 2018-01-08, under 510(k) number K171328.

Who is the listed applicant for cNeuro cMRI?

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

What is the FDA product code for cNeuro cMRI?

The FDA product code for cNeuro cMRI is LLZ.

Other records listing Combinostics OY 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.

K233908cNeuro cDAT K231576cNeuro cPET

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.