Philips Medical Systems Nederlands B.V.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Philips Medical Systems Nederlands B.V.” (first 2015, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 115 days. Since 2017 the median was 113 days, against 122 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Philips, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 141 |
| 2016 | 2 | 106 |
| 2017 | 0 | — |
| 2018 | 2 | 69 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 243 |
| 2022 | 1 | 39 |
| 2023 | 0 | — |
| 2024 | 1 | 117 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Philips Medical Systems Nederlands B.V. took a median 113 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 3 | 3 |
| OWB | Interventional Fluoroscopic X-Ray System | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Radiology (7)
- Cardiovascular (1)
Most recent Philips Medical Systems Nederlands B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240224 | Zenition 90 | OWB | 2024-05-22 | 117 |
| K223442 | MR 5300 and MR 7700 R11 MR Systems | LNH | 2022-12-23 | 39 |
| K201743 | ClarifEye R1.0, ClarifEye Needle | OWB | 2021-02-23 | 243 |
| K181311 | Philips Hemodynamic Application R1.0 | MWI | 2018-09-07 | 113 |
| K181966 | SmartPerfusion | OWB | 2018-08-17 | 25 |
| K162025 | IntelliSpace Portal Platform | LLZ | 2016-10-18 | 88 |
| K153324 | Ingenia 1.5T and Ingenia 1.5T S R5.2 | LNH | 2016-03-22 | 125 |
| K143128 | mDIXON XD | LNH | 2015-03-20 | 141 |
Recalls
openFDA lists no recalls under a recalling firm named Philips Medical Systems Nederlands B.V..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Philips Medical Systems Nederlands B.V. (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 LNH)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Philips Medical Systems, Inc. (218 510(k)s)
- Philips Medical Systems (Cleveland), Inc. (190 510(k)s)
- Philips Medical Systems Nederland B.V. (106 510(k)s)
- Philips Medical Systems North America, Inc. (95 510(k)s)
- Philips Ultrasound, Inc. (77 510(k)s)
- Philips Medizin Systeme Boeblingen GmbH (48 510(k)s)
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (25 510(k)s)
- Philips Health Care (20 510(k)s)
- Philips Hearing Instruments Co. (20 510(k)s)
- Philips Medical Systems Dmc GmbH (18 510(k)s)
- Philips Healthcare (Suzhou) Co., Ltd. (17 510(k)s)
- Philips Medizin Systeme Boblingen GmbH (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Philips Medical Systems Nederlands B.V.?
FDA lists 8 510(k) clearances under the applicant name “Philips Medical Systems Nederlands B.V.” (first 2015, latest 2024), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Philips Medical Systems Nederlands B.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Medical Systems Nederlands B.V. is 115 days. Since 2017: 113 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Philips Medical Systems Nederlands B.V.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 3); OWB (Interventional Fluoroscopic X-Ray System, 3); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 8 Philips Medical Systems Nederlands B.V. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Philips Medical Systems Nederlands B.V.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.