Cleared Special

K072468 - MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM

K072468 is an FDA 510(k) clearance for MODIFICATION TO D-SPECT CARDIAC SCANNER..., manufactured by Spectrum Dynamics , Ltd.. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 27-day FDA review.

K072468 · Spectrum Dynamics , Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
27d
Days
Class 2
Risk

K072468 is an FDA 510(k) clearance for the MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Spectrum Dynamics , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on October 1, 2007 after a review of 27 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 - K072468

510(k) Number K072468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2007
Decision Date October 01, 2007
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
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 440
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K072468.
MULTI-SPECT
K073021 · Eagle Heart Imaging, LLC · Nov 2007
SYMBIA-E, MODEL 10275879
K072567 · Siemens Medical Solutions USA, Inc. · Oct 2007
CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM
K072191 · Gvi Technology Partners · Oct 2007
SYSTEM, TOMOGRAPHY, COMPUTED EMISSION
K071503 · Syntermed, Inc. · Jul 2007
BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
K071068 · Siemens Medical Solutions USA, Inc. · May 2007
C!
K070589 · Transphoton Corporation · Apr 2007