Cleared Special

WBR XPRESS3.CARDIAC (K081201) - FDA 510(k) Clearance

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

K081201 · Ultraspect , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
30d
Days
Class 2
Risk

K081201 is an FDA 510(k) clearance for the WBR XPRESS3.CARDIAC. 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 May 28, 2008 after a review of 30 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 K081201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2008
Decision Date May 28, 2008
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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 K081201.
SYMBIA, VERSION 4.0
K082506 · Siemens Medical Solutions USA, Inc. · Nov 2008
BIOGRAPH HD FAMILY
K081453 · Siemens Medical Solutions USA, Inc. · Jun 2008
NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE
K081426 · Philips Medical Systems (Cleveland), Inc. · Jun 2008
GEMINI CONDOR
K081135 · Philips Medical Systems (Cleveland), Inc. · Apr 2008
BRIGHTVIEW VCT IMAGING SYSTEM
K080927 · Philips Medical Systems (Cleveland), Inc. · Apr 2008
SYMBIA-E, MODEL 10275879
K072567 · Siemens Medical Solutions USA, Inc. · Oct 2007