Philips Medical Systems Nederland B.V.: FDA clearances and approvals
Philips Medical Systems Nederland B.V. has 106 FDA 510(k) clearances (first 2005, latest 2026), plus 1 De Novo decision, across 14 product codes in 4 review panels. Median 510(k) review time: 92 days. Since 2017 its median was 86 days, against 121 days for all cleared 510(k)s in the same product codes. openFDA lists 209 product recalls by a recalling firm named Philips Medical Systems Nederland B.V.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 130 |
| 2013 | 11 | 121 |
| 2014 | 6 | 129 |
| 2015 | 3 | 147 |
| 2016 | 8 | 54 |
| 2017 | 10 | 78 |
| 2018 | 10 | 89 |
| 2019 | 3 | 101 |
| 2020 | 6 | 34 |
| 2021 | 8 | 117 |
| 2022 | 5 | 185 |
| 2023 | 4 | 84 |
| 2024 | 9 | 81 |
| 2025 | 8 | 97 |
| 2026 | 9 | 59 |
Review time against the same product codes
Since 2017, Philips Medical Systems Nederland B.V.'s cleared 510(k)s took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 29 | 29 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 27 | 27 |
| LLZ | System, Image Processing, Radiological | 17 | 17 |
| JAK | System, X-Ray, Tomography, Computed | 8 | 8 |
| PSY | Whole Slide Imaging System | 7 | 6 |
| MOS | Coil, Magnetic Resonance, Specialty | 6 | 6 |
| DQK | Computer, Diagnostic, Programmable | 4 | 4 |
| KPS | System, Tomography, Computed, Emission | 2 | 2 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
Plus 4 more product codes.
Review panels
- Radiology (93)
- Pathology (8)
- Cardiovascular (4)
- Anesthesiology (2)
Most recent Philips Medical Systems Nederland B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254205 | Zenition 30 | OWB | 2026-08-07 | 221 |
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T | MOS | 2026-07-30 | 21 |
| 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 | 2026-07-24 | 17 |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | MUJ | 2026-05-27 | 124 |
| K253614 | EchoNavigator R5.0 | QIH | 2026-03-17 | 119 |
| K260169 | AV Cardiac CT | JAK | 2026-03-05 | 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 | 2026-02-23 | 95 |
| K253735 | AV Vascular | QIH | 2026-01-22 | 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 | 2026-01-14 | 22 |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | DQK | 2025-10-24 | 64 |
96 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160056 | De Novo | Whole Slide Imaging System | 2017-04-12 |
Recalls
209 product recalls in 59 recall events; 208 initiated in the last five years. Most recent: 2026-07-16.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Philips Medical Systems Nederland B.V.'s product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances does Philips Medical Systems Nederland B.V. have?
Philips Medical Systems Nederland B.V. has 106 FDA 510(k) clearances (first 2005, latest 2026), plus 1 De Novo decision, across 14 product codes in 4 review panels.
How long does FDA take to clear Philips Medical Systems Nederland B.V.'s 510(k)s?
The median time from FDA receipt to decision across Philips Medical Systems Nederland B.V.'s cleared 510(k)s is 92 days. Since 2017: 86 days, versus 121 days for all cleared 510(k)s in the same product codes.
What devices does Philips Medical Systems Nederland B.V. make?
Its most frequent FDA product codes are OWB (Interventional Fluoroscopic X-Ray System, 29); LNH (System, Nuclear Magnetic Resonance Imaging, 27); LLZ (System, Image Processing, Radiological, 17).
Has Philips Medical Systems Nederland B.V. had device recalls?
openFDA lists 209 product recalls in 59 recall events by a recalling firm whose name matches Philips Medical Systems Nederland B.V; the most recent began 2026-07-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 106 Philips Medical Systems Nederland B.V. clearances with predicates and recalls
- Run predicate analysis for product code OWB, Philips Medical Systems Nederland B.V.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.