FDA.reportPublic FDA data

Philips India Limited - Image Guided Therapy Systems Business Unit

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30335272823033527282Philips India Limited - Image Guided Therapy Systems Business Unit1N2026-01-01Philips Innovation Campus, Embassy Business Hub, Venkatala Villa Bengaluru Karnataka IN 560064

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3331671379404817K254186Azurion R3.1OWB2026-01-16
3331671916947522K253670SmartCT (R3.0 (L10))OWB2026-07-10
3331671639753993K251827Azurion R3.1OWB2025-10-24
3331671897551169K201583SmartCT R1.0OWB2021-02-09
3331671527780676K200917Azurion R2.1OWB2020-05-01
3331671058397364K181177Interventional WorkspotLLZ2018-05-31
3331671193872912K172307Dynamic Coronary Roadmap 2.0OWB2017-10-24
3331671581271936K170144StentBoost LiveOWB2017-06-07
3331671798373098K162859Allura Xper FD series and Allura Xper OR Table seriesOWB2016-12-02
3331671605801965K160455AneurysmFlowOWB2016-08-25
3331671642566796K160147CT TrueViewOWB2016-08-10
3331671056337073K151598VesselNavigator Rel. 1.0OWB2015-08-17
3331671367815489K142273EmboGuideOWB2015-01-30
3331671682515816K142126EP NAVIGATOR REL. 5.0OWB2014-12-09
3331671822672968K140138HEARTNAVIGATOR RELEASE 2.0OWB2014-06-10
3331671956896087K132305STENTBOOST REL. 4OWB2013-10-30
3331671713397476K131263XPERGUIDEOWB2013-07-24
3331671903932962K130893XPERCT REL. 3OWB2013-09-06
3331672052815793K130638ALLURACLARITY XPER FD SERIES X-RAY SYSTEMOWB2013-06-28
3331671744810401K121772ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1OWB2013-03-21
3331671142493079K042334ALLURA 3D-CA, RELEASE 1LLZ2004-09-27
3331671121055954

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OWB192026-07-10
LLZ22018-05-31