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FDA 510(k)

VEA Align; spineEOS

K-Number: K251747 · 2025-08-15

ApplicantEos Imaging
Decision Date2025-08-15
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VEA Align; spineEOS is the device name listed in this FDA 510(k) record. The listed applicant is Eos Imaging. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K251747. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VEA Align; spineEOS?

VEA Align; spineEOS is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Eos Imaging. The 510(k) number is K251747.

When did VEA Align; spineEOS receive FDA 510(k) clearance?

VEA Align; spineEOS received FDA 510(k) clearance on 2025-08-15, under 510(k) number K251747.

Who is the listed applicant for VEA Align; spineEOS?

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 VEA Align; spineEOS?

The FDA product code for VEA Align; spineEOS is QIH.

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.

K251078AutoDensityK233920EOSedgeK240582VEA Align; spineEOSK231917VEA AlignK232086spineEOSK202394EOSedge

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Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

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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