FDA 510(k)

CliniscanSM MRI

K-Number: K153593 · 2016-02-17

Decision Date2016-02-17

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CliniscanSM MRI is the device name listed in this FDA 510(k) record. The listed applicant is Picofemto, LLC. It received FDA 510(k) clearance on 2016-02-17 under 510(k) number K153593. 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 CliniscanSM MRI?

CliniscanSM MRI is a medical device that received FDA 510(k) clearance on 2016-02-17. The listed applicant is Picofemto, LLC. The 510(k) number is K153593.

When did CliniscanSM MRI receive FDA 510(k) clearance?

CliniscanSM MRI received FDA 510(k) clearance on 2016-02-17, under 510(k) number K153593.

Who is the listed applicant for CliniscanSM MRI?

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

What is the FDA product code for CliniscanSM MRI?

The FDA product code for CliniscanSM MRI is LLZ.

Related Devices (Code: LLZ)

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.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.