Cleared Special

K120910 - CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL

K120910 is an FDA 510(k) clearance for CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE ..., manufactured by GE Medical Systems SCS. The device is a Class 2 Radiology device with product code JAK cleared through the Special 510(k) pathway after a 84-day FDA review.

K120910 · GE Medical Systems SCS · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
84d
Days
Class 2
Risk

K120910 is an FDA 510(k) clearance for the CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on June 18, 2012 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 - K120910

510(k) Number K120910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2012
Decision Date June 18, 2012
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 826
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K120910.
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K120910 · CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL
Download PDF FDA Summary GE Medical Systems SCS