Cleared Special

CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (K052430) - FDA 510(k) Clearance

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

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

Submission Details

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
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
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 148
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K052430.
BIOGRAPH 64 AND BIOGRAPH 40
K060631 · Siemens Medical Solutions USA, Inc. · Mar 2006
BIOGRAPH 6
K060060 · Siemens Medical Solutions USA, Inc. · Feb 2006
GEMINI RAPTOR
K052640 · Philips Medical Systems (Cleveland), Inc. · Oct 2005
GEMINI GXL
K051170 · Philips Medical Systems (Cleveland), Inc. · May 2005
GEMINI GXL
K042935 · Philips Medical Systems (Cleveland), Inc. · Nov 2004
C-PET PLUS IMAGING SYSTEM
K042839 · Philips Medical Systems (Cleveland), Inc. · Oct 2004