Philips Medical Systems Technologies , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Philips Medical Systems Technologies , Ltd.” (first 2018, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 127 days. Since 2017 the median was 127 days, against 127 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 |
|---|---|---|
| 2018 | 1 | 53 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 118 |
| 2025 | 1 | 141 |
| 2026 | 1 | 127 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Philips Medical Systems Technologies , Ltd. took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
Review panels
- Radiology (5)
Most recent Philips Medical Systems Technologies , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253649 | Spectral CT Verida Family | JAK | 2026-03-27 | 127 |
| K244008 | Spectral CT | JAK | 2025-05-16 | 141 |
| K240844 | Spectral CT 7500 RT | JAK | 2024-10-18 | 205 |
| K240822 | Image Management V15 | LLZ | 2024-04-24 | 30 |
| K173588 | Illumeo System | LLZ | 2018-01-12 | 53 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-10-10.
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.
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 Technologies , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Philips Medical Systems Technologies , Ltd.” (first 2018, latest 2026), across 2 product codes in 1 review panel. 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 Technologies , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Medical Systems Technologies , Ltd. is 127 days. Since 2017: 127 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Philips Medical Systems Technologies , Ltd.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 3); LLZ (System, Image Processing, Radiological, 2).
Next steps
- See all 5 Philips Medical Systems Technologies , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Philips Medical Systems Technologies , Ltd.'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.