WBR XPRESS3.CARDIAC— 510(k) K081201

Substantially Equivalent

Ultraspect , Ltd.

FDA 510(k) clearance K081201 for WBR XPRESS3.CARDIAC, Substantially Equivalent on 2008-05-28. Applicant: Ultraspect , Ltd.. Device class: 2.

Clearance details

Applicant: Ultraspect , Ltd.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2008-04-28
Decision date: 2008-05-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

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More clearances from Ultraspect , Ltd.

K103710 — WBR XPRESS PET2011-01-19
K091073 — WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS2009-05-14
K080784 — WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE2008-04-02
K050815 — XACT.CARDIAC & XPRESS.CARDIAC2005-04-26
K040370 — WBR-FHR, WBR-FWB2004-03-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.