BEUDAMED
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    BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 9, 2014

    BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 4, 2015

    Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.

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

    BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView XCT

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017

    BrightView XCT , Model Number 882482

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019

    BrightView XCT, Gamma Camera, Product Code 882482

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·September 14, 2016

    BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016

    882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016

    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017

    BrightView SPECT, Model Number 882480

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019

    BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025