Medical Device Manufacturer · NL , Best

Philips Medical Systems Nederland B.V.

102 submissions · 101 cleared · Since 2005
102
Total
101
Cleared
1
Denied

Philips Medical Systems Nederland B.V. — FDA 510(k) Submissions

Philips Medical Systems Nederland B.V. has submitted 102 FDA 510(k) premarket notifications since 2005, of which 101 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Interventional Fluoroscopic X-ray System, System, Nuclear Magnetic Resonance Imaging, System, Image Processing, Radiological, System, X-ray, Tomography, Computed, Whole Slide Imaging System . Use the specialty filter in the sidebar to narrow results.

102 devices
1–25 of 102
AV Cardiac CT
K260169 · JAK System, X-ray,... · Radiology
Mar 2026 44d
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
K253648 · LNH System, Nuclear Magnetic... · Radiology
Feb 2026 95d
AV Vascular
K253735 · QIH Automated Radiological... · Radiology
Jan 2026 59d
dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
K254190 · MOS Coil, Magnetic Resonance,... · Radiology
Jan 2026 22d
LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
K252645 · DQK Computer, Diagnostic,... · Cardiovascular
Oct 2025 64d
Philips IntelliSpace Cardiovascular
K251215 · LLZ System, Image Processing,... · Radiology
Oct 2025 167d
AV Viewer
K250181 · LLZ System, Image Processing,... · Radiology
Jul 2025 174d
Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems
K251808 · LNH System, Nuclear Magnetic... · Radiology
Jul 2025 29d
Philips iCT CT system
K250648 · JAK System, X-ray,... · Radiology
Jun 2025 115d
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
K251397 · LNH System, Nuclear Magnetic... · Radiology
Jun 2025 29d
Philips VSC-MEDlib
K242001 · BZQ Monitor, Breathing Frequency · Anesthesiology
Apr 2025 269d
Philips IntelliSite Pathology Solution 5.1
K243871 · PSY Whole Slide Imaging System · Pathology
Mar 2025 79d
Philips IntelliSite Pathology Solution 5.1
K242848 · PSY Whole Slide Imaging System · Pathology
Dec 2024 81d
Philips IntelliSite Pathology Solution
K241871 · PSY Whole Slide Imaging System · Pathology
Dec 2024 158d
ROCC Console
K242512 · LLZ System, Image Processing,... · Radiology
Oct 2024 62d
dS Knee Coil 8ch 1.5T
K242879 · MOS Coil, Magnetic Resonance,... · Radiology
Oct 2024 25d
dS Wrist coil 8ch 1.5T
K243033 · MOS Coil, Magnetic Resonance,... · Radiology
Oct 2024 21d
dS FootAnkle Coil 8ch 1.5T
K242096 · MOS Coil, Magnetic Resonance,... · Radiology
Aug 2024 25d
Philips IntelliSite Pathology Solution 5.1
K233204 · PSY Whole Slide Imaging System · Pathology
Jun 2024 270d
LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub
K233853 · DQK Computer, Diagnostic,... · Cardiovascular
Mar 2024 100d
Zenition 30
K232420 · OWB Interventional... · Radiology
Feb 2024 189d
Ingenia Elition R5.7.1 SP4 MR Systems
K232030 · LNH System, Nuclear Magnetic... · Radiology
Aug 2023 26d
AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
K223918 · DQK Computer, Diagnostic,... · Cardiovascular
Jun 2023 161d
Ingenia Elition and MR 7700 MR Systems
K230972 · LNH System, Nuclear Magnetic... · Radiology
Apr 2023 23d
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
K223458 · LNH System, Nuclear Magnetic... · Radiology
Apr 2023 141d

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