BEUDAMED
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    The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 20, 2012

    Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·May 7, 2012

    Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011

    Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011

    The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·May 7, 2012

    Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·July 11, 2017

    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 29, 2016

    Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 29, 2016

    Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·December 24, 2014

    728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

    FDA Recall
    Terminated ·Philips North America Llc·Product code JAK·June 8, 2021

    Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code JAK·July 31, 2014

    Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CGZ·September 26, 2007

    ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code CEM·July 22, 2014

    Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment , patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 26, 2012

    728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·August 25, 2021

    Brilliance iCT

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 1, 2017

    Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·May 13, 2020