Cleared Special

K080784 - WBR XPRESS.CARDIAC, WBR XPRESS.BONE

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

K080784 is an FDA 510(k) clearance for WBR XPRESS.CARDIAC, manufactured by Ultraspect , Ltd.. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 13-day FDA review.

K080784 · Ultraspect , Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K080784

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

KPS Device Classification - Class 2, Special Controls

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 456
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K080784.
CORRIDOR4DM
K080575 · Invia · May 2008
GEMINI CONDOR
K081135 · Philips Medical Systems (Cleveland), Inc. · Apr 2008
BRIGHTVIEW VCT IMAGING SYSTEM
K080927 · Philips Medical Systems (Cleveland), Inc. · Apr 2008
QUANTITATIVE NEUROQ 3.0
K072307 · Syntermed, Inc. · Mar 2008
VENTRI 1.1
K080124 · Ge Medical Systems F.I. Haifa · Jan 2008
MULTI-SPECT
K073021 · Eagle Heart Imaging, LLC · Nov 2007
K080784 · WBR XPRESS.CARDIAC, WBR XPRESS.BONE
Download PDF FDA Summary Ultraspect , Ltd.