Achieva, Ingenia, Ingenia CX, Ingenia Elition And Ingenia Ambition MR Systems
Philips Medical Systems Nederland B.V.
Philips Medical Systems Nederland B.V.
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3000976525 | 3000976525 | Philips Medical Systems Nederland B.V. | 1 | N | 2026-01-01 | High Tech Campus 36 Eindhoven Noord-Brabant NL 5656 AE |
| 3042175841 | 3042175841 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 1 | N | 2026-01-01 | VEENPLUIS 6 Best Noord-Brabant NL 5684 PC |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 344543 | 1881548544 | K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | DQK | 2025-10-24 |
| 218379 | 1211924612 | K251215 | Philips IntelliSpace Cardiovascular | LLZ | 2025-10-02 |
| 218379 | 1380672905 | K241659 | Ultrasound Workspace (UWS 6.0) | QIH | 2025-02-10 |
| 344543 | 1241909007 | K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | DQK | 2024-03-14 |
| 344543 | 1426558766 | K223918 | AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub | DQK | 2023-06-08 |
| 218379 | 1177659823 | K213544 | TOMTEC-ARENA | QIH | 2022-01-06 |
| 218379 | 2000661369 | K211046 | eCareManager 4.5 | MSX | 2022-06-03 |
| 344543 | 1992464836 | K201081 | AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter | DQK | 2020-12-17 |
| 218379 | 1988380984 | K200974 | QLAB Advanced Quantification Software | QIH | 2020-06-03 |
| 218379 | 2000658651 | K190913 | QLAB Advanced Quantification Software 13 | LLZ | 2019-06-18 |
| 218379 | 1424151033 | K181311 | Philips Hemodynamic Application R1.0 | MWI | 2018-09-07 |
| 218379 | 1049533428 | K181264 | QLAB Advanced Quantification Software | LLZ | 2018-06-07 |
| 218379 | 1151018245 | K180019 | CAAS Workstation | IZI | 2018-05-03 |
| 218379 | 1314221101 | K172609 | CSMC Cardiac Suite | KPS | 2017-11-03 |
| 218379 | 1330096492 | K171314 | QLAB Advanced Quantification Software | LLZ | 2017-05-30 |
| 218379 | 1854523488 | K153022 | Philips IntelliSpace Cardiovascular | LLZ | 2015-11-18 |
| 218379 | 1625130222 | K151780 | CAAS Workstation | IZI | 2016-03-11 |
| 218379 | 1758960621 | K150122 | TOMTEC-ARENA TTA2 | LLZ | 2015-02-13 |
| 218379 | 1586118179 | K141652 | CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE | KPS | 2014-07-22 |
| 218379 | 1210442860 | K101571 | XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS | MWI | 2010-10-26 |
| 218379 | 1896515130 | K061995 | XCELERA | LLZ | 2006-09-06 |
| 344543 | 1684049222 |
Product Codes Associated With Registrations
PMN
Spectral CT On Rails
Philips Medical Systems Nederland B.V.
MR 5300
Philips Medical Systems Nederland B.V.
Philips IntelliSite Pathology Solution
Philips Medical Systems Nederland B.V.
Vereos PET/CT
Philips Medical Systems Nederland B.V.
Vereos PET/CT
Philips Medical Systems Nederland B.V.
Spectral CT
Philips Medical Systems Nederland B.V.
The Multimodality Advanced Vessel Analysis
Philips Medical Systems Nederland B.V.
Stimuplex Onvision System
Philips Medical Systems Nederland B.V.
EchoNavigator
Philips Medical Systems Nederland B.V.
Achieva 1.5T, 3.0T And Intera 1.5T MR Systems
Philips Medical Systems Nederland B.V.
Brain Perfusion (BP) Application
Philips Medical Systems Nederland B.V.
Ingenia, Ingenia CX, Ingenia Elition, And Ingenia Ambition MR Systems
Philips Medical Systems Nederland B.V.
KODEX EPD System
Philips Medical Systems Nederland B.V.
Ingenia Ambition S And Ingenia Ambition X
Philips Medical Systems Nederland B.V.
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
Philips Medical Systems Nederland B.V.
Ingenia Elition S And Ingenia Elition X
Philips Medical Systems Nederland B.V.
Ingenia Elition S And Ingenia Elition X R5.4
Philips Medical Systems Nederland B.V.
3D APT
Philips Medical Systems Nederland B.V.
Advanced Diffusion Analysis (ADA) Application
Philips Medical Systems Nederland B.V.
Dynamic Coronary Roadmap 2.0
Philips Medical Systems Nederland B.V.
Philips IntelliSite Pathology Solution
Philips Medical Systems Nederland B.V.
Longitudinal Brain Imaging (LoBI) Application
Philips Medical Systems Nederland B.V.
Lung Nodule Assessment And Comparison Option (LNA)
Philips Medical Systems Nederland B.V.
Ingenia 1.5T, Ingenia 1.5T S And Ingenia 3.0T R5.3
Philips Medical Systems Nederland B.V.
Ingenia 1.5T CX And Ingenia 3.0T CX R5.3
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
MultiBand SENSE
Philips Medical Systems Nederland B.V.
Multi-Modality Tumor Tracking (MMTT) Application
Philips Medical Systems Nederland B.V.
EmboGuide
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
EP NAVIGATOR REL. 5.0
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
VERADIUS
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
MR ELASTOGRAPHY
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
HEARTNAVIGATOR RELEASE 2.0
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA XPER FD; OR TABLE
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
MDIXON-QUANT
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2D PERFUSION
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
STENTBOOST REL. 4
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
PHILIPS HERCEPTEST DIGITAL SCORE
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
XPERCT REL. 3
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SWIP
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
GUDID
IntelliSpace PACS Anywhere
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
MR 7700
Philips Medical Systems Nederland B.V.
MR 7700
Philips Medical Systems Nederland B.V.
Ingenia, MR5300, MR7700, Achieva
Philips Medical Systems Nederland B.V.
Ingenia Elition
Philips Medical Systems Nederland B.V.
Ingenia 3.0T
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Spectral CT 7500 RT
Philips Medical Systems Nederland B.V.
MR Coils
Philips Medical Systems Nederland B.V.
MR Coils
Philips Medical Systems Nederland B.V.
MR Coils
Philips Medical Systems Nederland B.V.
MR Coils
Philips Medical Systems Nederland B.V.
Magnetic Resonance Imaging Systems
Philips Medical Systems Nederland B.V.
DUNLEE
Philips Medical Systems Nederland B.V.
IntelliSpace Cardiovascular
Philips Medical Systems Nederland B.V.
Ingenia, Achevia, MR 5300
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
MR 7700
Philips Medical Systems Nederland B.V.
MR 7700
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia, MR 5300, MR 7700, Achieva
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.
Ingenia
Philips Medical Systems Nederland B.V.