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FDA 510(k)

MAXINSIGHT

K-Number: K070358 · 2007-07-30

ApplicantEemagine Medical Imaging Solutions GmbH
Decision Date2007-07-30
Product CodeOLX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAXINSIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Eemagine Medical Imaging Solutions GmbH. It received FDA 510(k) clearance on 2007-07-30 under 510(k) number K070358. The device is classified under product code OLX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXINSIGHT?

MAXINSIGHT is a medical device that received FDA 510(k) clearance on 2007-07-30. The listed applicant is Eemagine Medical Imaging Solutions GmbH. The 510(k) number is K070358.

When did MAXINSIGHT receive FDA 510(k) clearance?

MAXINSIGHT received FDA 510(k) clearance on 2007-07-30, under 510(k) number K070358.

Who is the listed applicant for MAXINSIGHT?

The FDA 510(k) record lists Eemagine Medical Imaging Solutions GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXINSIGHT?

The FDA product code for MAXINSIGHT is OLX.

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Other records listing Eemagine Medical Imaging Solutions GmbH as applicant

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Related Devices (Code: OLX)

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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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