Cleared Special

K091073 - WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS

K091073 is an FDA 510(k) clearance for WBR XPRESS.CARDIAC AND XPRESS3.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 30-day FDA review.

K091073 · Ultraspect , Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
30d
Days
Class 2
Risk

K091073 is an FDA 510(k) clearance for the WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING C.... 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 14, 2009 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.

FDA 510(k) Submission Details - K091073

510(k) Number K091073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2009
Decision Date May 14, 2009
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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 457
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K091073.
MODIFICATION TO SCINTRON IV
K101013 · Miegmbh · Jun 2010
DISCOVERY MODEL NM/CT 670
K093514 · Ge Medical Systems F.I. Haifa · Dec 2009
INSPIRA HD, MODEL: NL1000
K090811 · Neurologica Corporation · Aug 2009
NEUROPET
K091269 · Photodetection Systems, Inc. · May 2009
ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8
K090178 · Neusoft Positron Medical Systems Co., Ltd. · Apr 2009
AUTOSPECT
K090403 · Philips Medical Systems (Cleveland), Inc. · Mar 2009
K091073 · WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS
Download PDF FDA Summary Ultraspect , Ltd.