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FDA 510(k)

SCANSCOPE XT SYSTEM

K-Number: K080254 · 2008-10-31

ApplicantAperio Technologies
Decision Date2008-10-31
Product CodeOEO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SCANSCOPE XT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aperio Technologies. It received FDA 510(k) clearance on 2008-10-31 under 510(k) number K080254. The device is classified under product code OEO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANSCOPE XT SYSTEM?

SCANSCOPE XT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-31. The listed applicant is Aperio Technologies. The 510(k) number is K080254.

When did SCANSCOPE XT SYSTEM receive FDA 510(k) clearance?

SCANSCOPE XT SYSTEM received FDA 510(k) clearance on 2008-10-31, under 510(k) number K080254.

Who is the listed applicant for SCANSCOPE XT SYSTEM?

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

What is the FDA product code for SCANSCOPE XT SYSTEM?

The FDA product code for SCANSCOPE XT SYSTEM is OEO.

Related Clinical Trials

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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Other records listing Aperio Technologies 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.

K080564SCANSCOPE XT SYSTEMK073677SCANSCOPE XT SYSTEMK071671SCANSCOPE XT SYSTEMK071128SCANSCOPE XT SYSTEM

Related Devices (Code: OEO)

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.

K130021PHILIPS HERCEPTEST DIGITAL SCOREPhilips Medical Systems Nederland B.V.K111914VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEMOlympus America Inc. / Scientific Equipment GroupK071671SCANSCOPE XT SYSTEMAperio Technologies

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.

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