Philips Healthcare (Suzhou) Co., Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Philips Healthcare (Suzhou) Co., Ltd.” (first 2014, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Since 2017 the median was 90 days, against 116 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 |
|---|---|---|
| 2014 | 1 | 16 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 30 |
| 2018 | 2 | 146 |
| 2019 | 1 | 91 |
| 2020 | 1 | 23 |
| 2021 | 3 | 199 |
| 2022 | 2 | 160 |
| 2023 | 1 | 56 |
| 2024 | 3 | 104 |
| 2025 | 0 | — |
| 2026 | 2 | 108 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Philips Healthcare (Suzhou) Co., Ltd. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 8 | 8 |
| MOS | Coil, Magnetic Resonance, Specialty | 4 | 4 |
| KPR | System, X-Ray, Stationary | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
Review panels
- Radiology (17)
Most recent Philips Healthcare (Suzhou) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | JAK | 2026-03-23 | 186 |
| K260519 | Smart Fit TorsoCardiac 1.5T | MOS | 2026-03-20 | 31 |
| K242329 | CT Collaboration Live | LLZ | 2024-11-18 | 104 |
| K232491 | CT 5300 | JAK | 2024-05-03 | 260 |
| K233600 | Smart Fit Knee 3.0T | MOS | 2024-02-05 | 88 |
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | MOS | 2023-09-01 | 56 |
| K223311 | Philips CT 3500 | JAK | 2022-12-22 | 55 |
| K212441 | Philips Incisive CT | JAK | 2022-04-27 | 266 |
| K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | MOS | 2021-12-01 | 84 |
| K211168 | Philips Incisive CT on Trailer | JAK | 2021-11-22 | 217 |
7 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 4 recall events; 3 initiated in the last five years. Most recent: 2026-06-26.
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 Healthcare (Suzhou) Co., Ltd. (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)
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 Medizin Systeme Boblingen GmbH (12 510(k)s)
- Philips Int'L B.V. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Philips Healthcare (Suzhou) Co., Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Philips Healthcare (Suzhou) Co., Ltd.” (first 2014, latest 2026), across 5 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 Healthcare (Suzhou) Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Healthcare (Suzhou) Co., Ltd. is 88 days. Since 2017: 90 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Philips Healthcare (Suzhou) Co., Ltd.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 8); MOS (Coil, Magnetic Resonance, Specialty, 4); KPR (System, X-Ray, Stationary, 3).
Next steps
- See all 17 Philips Healthcare (Suzhou) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Philips Healthcare (Suzhou) Co., 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.