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FDA 510(k)

Neo

K-Number: K192889 · 2020-01-30

ApplicantEemagine Medical Imaging Solutions GmbH
Decision Date2020-01-30
Product CodeOMA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neo 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 2020-01-30 under 510(k) number K192889. The device is classified under product code OMA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neo?

Neo is a medical device that received FDA 510(k) clearance on 2020-01-30. The listed applicant is Eemagine Medical Imaging Solutions GmbH. The 510(k) number is K192889.

When did Neo receive FDA 510(k) clearance?

Neo received FDA 510(k) clearance on 2020-01-30, under 510(k) number K192889.

Who is the listed applicant for Neo?

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 Neo?

The FDA product code for Neo is OMA.

Other records listing Eemagine Medical Imaging Solutions GmbH as applicant

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.

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Related Devices (Code: OMA)

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.

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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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