FDA 510(k) Applications Submitted by PHILIPS MEDICAL SYSTEMS NEDERLAND BV

FDA 510(k) Number Submission Date Device Name Applicant
K181177 05/02/2018 Interventional Workspot Philips Medical Systems Nederland BV
K170130 01/13/2017 Dynamic Coronary Roadmap Philips Medical Systems Nederland BV
K160315 02/05/2016 I4 (Integrated Intelligent Imaging Informatics) system PHILIPS MEDICAL SYSTEMS NEDERLAND BV
K193215 11/21/2019 Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland BV
K160147 01/21/2016 CT TrueView PHILIPS MEDICAL SYSTEMS NEDERLAND BV
K160455 02/18/2016 AneurysmFlow PHILIPS MEDICAL SYSTEMS NEDERLAND BV
K161563 06/06/2016 Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland BV
K161839 07/05/2016 2D Quantitative Analysis PHILIPS MEDICAL SYSTEMS NEDERLAND BV
K172822 09/18/2017 Azurion series R1.2 Philips Medical Systems Nederland BV
K162859 10/12/2016 Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland BV
K163715 12/30/2016 Allura Xper R9 PHILIPS MEDICAL SYSTEMS NEDERLAND BV
K151598 06/12/2015 VesselNavigator Rel. 1.0 PHILIPS MEDICAL SYSTEMS NEDERLAND BV
K200917 04/06/2020 Azurion R2.1 Philips Medical Systems Nederland BV
K181830 07/09/2018 Azurion R2.0 Philips Medical Systems Nederland BV
K183040 11/01/2018 Zenition 70 Philips Medical Systems Nederland BV
K183101 11/07/2018 Zenition 50 Philips Medical Systems Nederland BV
K212813 09/03/2021 Zenition 70 Philips Medical Systems Nederland BV


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact