Philips Healthcare (Suzhou) Co., Ltd. FDA Approvals

0 new drug approvals and 11 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
CT Rembra RT; CT Areta RT; CT Rembra510(k)Mar 23, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 23, 2026
Smart Fit TorsoCardiac 1.5T510(k)Mar 20, 2026Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 20, 2026
CT Collaboration Live510(k)Nov 18, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 18, 2024
CT 5300510(k)May 3, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 3, 2024
Smart Fit Knee 3.0T510(k)Feb 5, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 5, 2024
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T510(k)Sep 1, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 1, 2023
Philips CT 3500510(k)Dec 22, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 22, 2022
Philips Incisive CT510(k)Apr 27, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 27, 2022
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T510(k)Dec 1, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 1, 2021
Philips Incisive CT on Trailer510(k)Nov 22, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 22, 2021
Precise Position510(k)Jun 17, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 17, 2021