9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or later) Product Usage: The IntelliBridge System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. The system is not intended for monitoring purposes, nor is the system intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to. The IntelliBridge solution is intended for use in professional healthcare facilities by trained healthcare professionals.
FDA Enforcement
Class III
·Terminated·Philips North America, LLC·June 19, 2019
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·September 26, 2012
Ingenuity Core Computed Tomography X-ray system, Model 728321
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Ingenuity Core 128 Computed Tomography X-ray system, Model 728323
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Brilliance ICT SP Computed Tomography X-ray system, Model 728311
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Brilliance iCT Computed Tomography X-ray system, Model 728306
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Ingenuity CT Computed Tomography X-ray system, Model 728326
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
IQon Spectral CT Computed Tomography X-ray system, Model 728332
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
BrightView X 3/8 model number 882478 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 III
·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017