Cleared Special

K052430 - CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM

K052430 is an FDA 510(k) clearance for CARDIUS-1, manufactured by Digirad Corp.. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 28-day FDA review.

K052430 · Digirad Corp. · Radiology device
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Oct 2005
Decision
28d
Days
Class 2
Risk

K052430 is an FDA 510(k) clearance for the CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Digirad Corp. (Poway, US). The FDA issued a Cleared decision on October 4, 2005 after a review of 28 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 Digirad Corp. devices

FDA 510(k) Submission Details - K052430

510(k) Number K052430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2005
Decision Date October 04, 2005
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
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 372
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K052430.
AUTOQUANT PLUS
K060020 · Adac Laboratories · Jan 2006
CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2
K053062 · Cardiarc , Ltd. · Jan 2006
GEMINI RAPTOR
K052640 · Philips Medical Systems (Cleveland), Inc. · Oct 2005
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
K052434 · GE Medical Systems · Sep 2005
VENTRI
K051855 · Ge Medical Systems F.I. Haifa · Aug 2005
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
K051549 · Digirad Corp. · Jul 2005