3 results
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28ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Philips Incisive CT
FDA Enforcement
Class II
·Ongoing·Philips Healthcare (Suzhou) Co., Ltd.·January 14, 2026
Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.
FDA Enforcement
Class II
·Terminated·Philips Healthcare (Suzhou) Co., Ltd.·March 24, 2021
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
FDA Enforcement
Class II
·Ongoing·Philips Healthcare (Suzhou) Co., Ltd.·January 17, 2024