Philips Healthcare (Suzhou) Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 5 device types, 15 products catalogued, 17 clearances.
Philips Healthcare (Suzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers System, X-Ray, Stationary, Coil, Magnetic Resonance, Specialty and 3 other device types. 15 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2014.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3009529630 |
| FEI number | 3009529630 |
| DUNS | 421265537 |
| Establishment type | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 飞利浦医疗（苏州）有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No. 258, Zhongyuan Road |
| Postal code | 215024 |
| Country | China |
Group
Philips Healthcare (Suzhou) Co., Ltd. is one of 5 plants registered under Philips Medical Systems International BV.
| Plant | City | Device types |
|---|---|---|
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | 6 |
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | 5 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | 1 |
| Philips Goldway (Shenzhen) Industrial Inc. | Shenzhen | 7 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | Class 2 | Smart Fit Knee 3T, Smart Fit Shoulder 1.5T, Smart Fit TorsoCardiac 1.5T, dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | 2022 | 9 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class 2 | DuraDiagnost | 2014 | 13 |
| System, Planning, Radiation Therapy Treatment | Class 2 | Multimodality Simulation Workspace (MM Sim) | 2026 | 5 |
| System, X-Ray, Stationary | Class 2 | DigitalDiagnost C50, DuraDiagnost, 712201, DigitalDiagnost C50 | 2014 | 7 |
| System, X-Ray, Tomography, Computed | Class 2 | Brilliance CT Big Bore, Philips CT Big Bore, Incisive CT, Spectral CT 7500 RT, Spectral CT, CT Rembra RT and 5 more | 2017 | 8 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| DigitalDiagnost C50 | KPR | 2 |
| Incisive CT | JAK | 2 |
| dS MSK S 1.5T | MOS | 2 |
| dS MSK M 1.5T | MOS | 2 |
| CT Rembra RT | JAK | 1 |
| DuraDiagnost | MQB | 1 |
| Smart Fit Shoulder 1.5T | MOS | 1 |
| CT 5300 | JAK | 1 |
| DuraDiagnost Compact | KPR | 1 |
| DuraDiagnost | KPR | 1 |
| dS TorsoCardiac 1.5T | MOS | 1 |
| Smart Fit Knee 3.0T | MOS | 1 |
| Smart Fit TorsoCardiac 1.5T | MOS | 1 |
| CT Areta RT | JAK | 1 |
| CT Rembra | JAK | 1 |
Clearances
17 clearances name Philips Healthcare (Suzhou) Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252992 | 2026-03-23 | JAK | Traditional | This company |
| K260519 | 2026-03-20 | MOS | Special | This company |
| K242329 | 2024-11-18 | LLZ | Traditional | This company |
| K232491 | 2024-05-03 | JAK | Traditional | This company |
| K233600 | 2024-02-05 | MOS | Traditional | This company |
| K232021 | 2023-09-01 | MOS | Traditional | This company |
| K223311 | 2022-12-22 | JAK | Traditional | This company |
| K212441 | 2022-04-27 | JAK | Traditional | This company |
| K212864 | 2021-12-01 | MOS | Traditional | This company |
| K211168 | 2021-11-22 | JAK | Traditional | This company |
| K203514 | 2021-06-17 | JAK | Traditional | This company |
| K201640 | 2020-07-09 | KPR | Special | This company |
| K191136 | 2019-07-29 | JAK | Traditional | This company |
| K173507 | 2018-06-15 | LNH | Abbreviated | This company |
| K180015 | 2018-03-20 | JAK | Traditional | This company |
| K163410 | 2017-01-04 | KPR | Special | This company |
| K141381 | 2014-06-12 | KPR | Traditional | This company |
| K201725 | 2020-07-10 | KPR | Special | Philips Healthcare (Suzhou) Co., Lit. |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-06-26 | Class II | Radiation Control for Health and Safety Act | Potential of failing to trigger clinical scan during Bolus Tracking. | ||
| 2025-12-03 | Class II | Radiation Control for Health and Safety Act | Potential for incomplete scan due to unstable connection inside of floating sensor. | 35 | |
| 2022-12-23 | Class II | Software design | Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation | 828 | |
| 2021-02-24 | Class II | Process control | Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position. | 109 systems | 2023-02-17 |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability.
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