FDA 510(k)

WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE

K-Number: K080784 · 2008-04-02

Decision Date2008-04-02

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE is the device name listed in this FDA 510(k) record. The listed applicant is Ultraspect , Ltd.. It received FDA 510(k) clearance on 2008-04-02 under 510(k) number K080784. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE?

WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE is a medical device that received FDA 510(k) clearance on 2008-04-02. The listed applicant is Ultraspect , Ltd.. The 510(k) number is K080784.

When did WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE receive FDA 510(k) clearance?

WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE received FDA 510(k) clearance on 2008-04-02, under 510(k) number K080784.

Who is the listed applicant for WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE?

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

What is the FDA product code for WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE?

The FDA product code for WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE is KPS.

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Other records listing Ultraspect , Ltd. as applicant

K103710WBR XPRESS PET K091073WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS K081201WBR XPRESS3.CARDIAC K050815XACT.CARDIAC & XPRESS.CARDIAC K040370WBR-FHR, WBR-FWB

Related Devices (Code: KPS)

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.