Cleared Special

WBR XPRESS.CARDIAC, WBR XPRESS.BONE (K080784) - FDA 510(k) Clearance

Also marketed or referenced as:
WBR XACT.CARDIAC, WBR XACT.BONE

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K080784 · Ultraspect , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
13d
Days
Class 2
Risk

K080784 is an FDA 510(k) clearance for the WBR XPRESS.CARDIAC, WBR XPRESS.BONE. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ultraspect , Ltd. (Haifa, IL). The FDA issued a Cleared decision on April 2, 2008 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ultraspect , Ltd. devices

Submission Details

510(k) Number K080784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2008
Decision Date April 02, 2008
Days to Decision 13 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 165
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K080784.
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BRIGHTVIEW VCT IMAGING SYSTEM
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SYMBIA-E, MODEL 10275879
K072567 · Siemens Medical Solutions USA, Inc. · Oct 2007
BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
K071068 · Siemens Medical Solutions USA, Inc. · May 2007
BIOGRAPH 64 AND BIOGRAPH 40
K060631 · Siemens Medical Solutions USA, Inc. · Mar 2006