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FDA 510(k)

XACT.CARDIAC & XPRESS.CARDIAC

K-Number: K050815 · 2005-04-26

ApplicantUltraspect , Ltd.
Decision Date2005-04-26
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XACT.CARDIAC & XPRESS.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 2005-04-26 under 510(k) number K050815. 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 XACT.CARDIAC & XPRESS.CARDIAC?

XACT.CARDIAC & XPRESS.CARDIAC is a medical device that received FDA 510(k) clearance on 2005-04-26. The listed applicant is Ultraspect , Ltd.. The 510(k) number is K050815.

When did XACT.CARDIAC & XPRESS.CARDIAC receive FDA 510(k) clearance?

XACT.CARDIAC & XPRESS.CARDIAC received FDA 510(k) clearance on 2005-04-26, under 510(k) number K050815.

Who is the listed applicant for XACT.CARDIAC & XPRESS.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 XACT.CARDIAC & XPRESS.CARDIAC?

The FDA product code for XACT.CARDIAC & XPRESS.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 CORRECTIONSK081201WBR XPRESS3.CARDIACK080784WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONEK040370WBR-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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