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FDA 510(k)

WBR XPRESS3.CARDIAC

K-Number: K081201 · 2008-05-28

ApplicantUltraspect , Ltd.
Decision Date2008-05-28
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WBR XPRESS3.CARDIAC is the device name listed in this FDA 510(k) record. The listed applicant is Ultraspect , Ltd.. It received FDA 510(k) clearance on 2008-05-28 under 510(k) number K081201. 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 XPRESS3.CARDIAC?

WBR XPRESS3.CARDIAC is a medical device that received FDA 510(k) clearance on 2008-05-28. The listed applicant is Ultraspect , Ltd.. The 510(k) number is K081201.

When did WBR XPRESS3.CARDIAC receive FDA 510(k) clearance?

WBR XPRESS3.CARDIAC received FDA 510(k) clearance on 2008-05-28, under 510(k) number K081201.

Who is the listed applicant for WBR XPRESS3.CARDIAC?

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 XPRESS3.CARDIAC?

The FDA product code for WBR XPRESS3.CARDIAC is KPS.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ultraspect , Ltd. 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.

K103710WBR XPRESS PETK091073WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONSK080784WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONEK050815XACT.CARDIAC & XPRESS.CARDIACK040370WBR-FHR, WBR-FWB

Related Devices (Code: KPS)

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.

K261305MICSI-PETMicrostructure Imaging, Inc.K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 FamilySiemens Medical Solutions USA, Inc.K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)Spectrum Dynamics Medical, Ltd.

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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