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FDA 510(k)

sterEOS Workstation

K-Number: K172346 · 2018-06-19

ApplicantEos Imaging
Decision Date2018-06-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

sterEOS Workstation is the device name listed in this FDA 510(k) record. The listed applicant is Eos Imaging. It received FDA 510(k) clearance on 2018-06-19 under 510(k) number K172346. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the sterEOS Workstation?

sterEOS Workstation is a medical device that received FDA 510(k) clearance on 2018-06-19. The listed applicant is Eos Imaging. The 510(k) number is K172346.

When did sterEOS Workstation receive FDA 510(k) clearance?

sterEOS Workstation received FDA 510(k) clearance on 2018-06-19, under 510(k) number K172346.

Who is the listed applicant for sterEOS Workstation?

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 sterEOS Workstation?

The FDA product code for sterEOS Workstation is LLZ.

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.

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Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, 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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