Medical device manufacturer
Philips Medical Systems Nederland B.V.
Philips Medical Systems Nederland B.V. holds 104 FDA 510(k) clearances across 14 product codes. Median elapsed review time is 89 days. openFDA lists 206 recall records naming the company. FDA publishes it under 7 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 104
- Product codes
- 14
- Median review
- 89 days
- Recall records
- 206
How does FDA spell Philips Medical Systems Nederland B.V.?
FDA publishes this company under 7 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | device/recall | normalised |
| PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | device/enforcement | normalised |
| PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | device/registrationlisting | normalised |
| Philips Medical Systems Nederland B.V. | device/enforcement | normalised |
| Philips Medical Systems Nederland B.V. | device/recall | normalised |
| Philips Medical Systems Nederland B.V. | device/510k | normalised |
| Philips Medical Systems Nederland B.V. | device/registrationlisting | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Philips Medical Systems Nederland B.V. file in?
14 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 28 | 98 days | |
| LNH | System, Nuclear Magnetic Resonance Imaging | 27 | 89 days | |
| LLZ | System, Image Processing, Radiological | 17 | 87 days | |
| JAK | System, X-Ray, Tomography, Computed | 8 | 115 days | |
| PSY | Whole Slide Imaging System | 6 | 81 days | |
| MOS | Coil, Magnetic Resonance, Specialty | 5 | 22 days | |
| DQK | Computer, Diagnostic, Programmable | 4 | 100 days | |
| KPS | System, Tomography, Computed, Emission | 2 | 56 days | |
| QIH | Automated Radiological Image Processing Software | 2 | 59 days | |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 225 days | |
| BZQ | Monitor, Breathing Frequency | 1 | 269 days | |
| IZI | System, X-Ray, Angiographic | 1 | 55 days | |
| MUJ | System, Planning, Radiation Therapy Treatment | 1 | 124 days | |
| OEO | Automated Digital Image Manual Interpretation Microscope | 1 | 259 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Philips Medical Systems Nederland B.V. had a recall?
openFDA lists 206 recall records naming this company across its whole history, of which 93 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2891-2026Open, ClassifiedOWB
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Z-2892-2026Open, ClassifiedOWB
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Z-2893-2026Open, ClassifiedOWB
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Z-2411-2026Class IIOpen, ClassifiedIZI
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
Z-2412-2026Class IIOpen, ClassifiedOWB
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
Showing the 5 most recently initiated of 206.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Philips Medical Systems Nederland B.V. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T | MOS | 17 | |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | MUJ | 124 | |
| K253614 | EchoNavigator R5.0 | QIH | 119 | |
| K260169 | AV Cardiac CT | JAK | 44 | |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | LNH | 95 | |
| K253735 | AV Vascular | QIH | 59 | |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | MOS | 22 | |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | DQK | 64 | |
| K251215 | Philips IntelliSpace Cardiovascular | LLZ | 167 | |
| K250181 | AV Viewer | LLZ | 174 |
Source: openFDA device/510k · retrieved
Where is Philips Medical Systems Nederland B.V. registered?
FDA lists 7 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Philips Medical Systems Nederland B.V. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.