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FDA 510(k)

CliniscanSM MRI

K-Number: K153593 · 2016-02-17

ApplicantPicofemto, LLC
Decision Date2016-02-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CliniscanSM MRI is a medical device manufactured by Picofemto, LLC. It received FDA 510(k) clearance on 2016-02-17 under approval 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. It is manufactured by Picofemto, LLC. The 510(k) number is K153593.

When was CliniscanSM MRI approved by the FDA?

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

What company makes CliniscanSM MRI?

CliniscanSM MRI is manufactured by Picofemto, LLC.

What is the FDA product code for CliniscanSM MRI?

The FDA product code for CliniscanSM MRI is LLZ.

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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.

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