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FDA 510(k)

EOSedge

K-Number: K202394 · 2020-09-16

ApplicantEos Imaging
Decision Date2020-09-16
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EOSedge is the device name listed in this FDA 510(k) record. The listed applicant is Eos Imaging. It received FDA 510(k) clearance on 2020-09-16 under 510(k) number K202394. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EOSedge?

EOSedge is a medical device that received FDA 510(k) clearance on 2020-09-16. The listed applicant is Eos Imaging. The 510(k) number is K202394.

When did EOSedge receive FDA 510(k) clearance?

EOSedge received FDA 510(k) clearance on 2020-09-16, under 510(k) number K202394.

Who is the listed applicant for EOSedge?

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

What is the FDA product code for EOSedge?

The FDA product code for EOSedge is KPR.

Other records listing Eos Imaging 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.

View all 10 devices →

Related Devices (Code: KPR)

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.

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.