Cleared Special

K050815 - XACT.CARDIAC & XPRESS.CARDIAC

K050815 is an FDA 510(k) clearance for XACT.CARDIAC & 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 26-day FDA review.

K050815 · Ultraspect , Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
26d
Days
Class 2
Risk

K050815 is an FDA 510(k) clearance for the XACT.CARDIAC & XPRESS.CARDIAC. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ultraspect , Ltd. (Hafia, IL). The FDA issued a Cleared decision on April 26, 2005 after a review of 26 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 - K050815

510(k) Number K050815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2005
Decision Date April 26, 2005
Days to Decision 26 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
81d faster than avg
Panel avg: 107d · This submission: 26d
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 K050815.
C.CAM-AC
K051460 · Danish Diagnostic Development A/S · Jun 2005
PRECEDENCE SPECT/CT IMAGING SYSTEM
K051351 · Adac Laboratories · Jun 2005
GEMINI GXL
K051170 · Philips Medical Systems (Cleveland), Inc. · May 2005
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I
K050509 · Cti Pet Systems, Inc. · Mar 2005
IMAGENPRO
K050366 · Cardiovascular Imaging Technologies, LLC · Mar 2005
GE DISCOVERY VCT SYSTEM
K050559 · GE Medical Systems · Mar 2005
K050815 · XACT.CARDIAC & XPRESS.CARDIAC
Download PDF FDA Summary Ultraspect , Ltd.