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FDA 510(k)

O-SCAN MR SYSTEM

K-Number: K092469 · 2009-12-23

ApplicantEsaote, S.p.A.
Decision Date2009-12-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

O-SCAN MR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2009-12-23 under 510(k) number K092469. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O-SCAN MR SYSTEM?

O-SCAN MR SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is Esaote, S.p.A.. The 510(k) number is K092469.

When did O-SCAN MR SYSTEM receive FDA 510(k) clearance?

O-SCAN MR SYSTEM received FDA 510(k) clearance on 2009-12-23, under 510(k) number K092469.

Who is the listed applicant for O-SCAN MR SYSTEM?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O-SCAN MR SYSTEM?

The FDA product code for O-SCAN MR SYSTEM is LNH.

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Related Devices (Code: LNH)

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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.

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