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FDA 510(k)

MODIFICATION TO E-SCAN XQ MRI SYSTEM

K-Number: K041145 · 2004-05-14

ApplicantEsaote, S.p.A.
Decision Date2004-05-14
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO E-SCAN XQ MRI 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 2004-05-14 under 510(k) number K041145. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO E-SCAN XQ MRI SYSTEM?

MODIFICATION TO E-SCAN XQ MRI SYSTEM is a medical device that received FDA 510(k) clearance on 2004-05-14. The listed applicant is Esaote, S.p.A.. The 510(k) number is K041145.

When did MODIFICATION TO E-SCAN XQ MRI SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO E-SCAN XQ MRI SYSTEM received FDA 510(k) clearance on 2004-05-14, under 510(k) number K041145.

Who is the listed applicant for MODIFICATION TO E-SCAN XQ MRI 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 MODIFICATION TO E-SCAN XQ MRI SYSTEM?

The FDA product code for MODIFICATION TO E-SCAN XQ MRI SYSTEM is MOS.

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Other records listing Esaote, S.p.A. as applicant

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Related Devices (Code: MOS)

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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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