Philips Healthcare (Suzhou) Co., Ltd.
Suzhou Jiangsu, CN
Philips Healthcare (Suzhou) Co., Ltd. appears in FDA device records in Suzhou Jiangsu, CN. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Philips Healthcare (Suzhou) Co., Ltd. between 2014 and 2026. The busiest year on record is 2021, with 3. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 3 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | JAK | Substantially Equivalent | |
| K260519 | Smart Fit TorsoCardiac 1.5T | MOS | Substantially Equivalent | |
| K242329 | CT Collaboration Live | LLZ | Substantially Equivalent | |
| K232491 | CT 5300 | JAK | Substantially Equivalent | |
| K233600 | Smart Fit Knee 3.0T | MOS | Substantially Equivalent | |
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | MOS | Substantially Equivalent | |
| K223311 | Philips CT 3500 | JAK | Substantially Equivalent | |
| K212441 | Philips Incisive CT | JAK | Substantially Equivalent | |
| K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | MOS | Substantially Equivalent | |
| K211168 | Philips Incisive CT on Trailer | JAK | Substantially Equivalent | |
| K203514 | Precise Position | JAK | Substantially Equivalent | |
| K201640 | DuraDiagnost | KPR | Substantially Equivalent | |
| K191136 | Access CT | JAK | Substantially Equivalent | |
| K173507 | Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 | LNH | Substantially Equivalent | |
| K180015 | Philips Incisive CT | JAK | Substantially Equivalent | |
| K163410 | DigitalDiagnost C50 | KPR | Substantially Equivalent | |
| K141381 | DURADIAGNOST | KPR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009529630 | 3009529630 | Philips Healthcare (Suzhou) Co., Ltd. | No. 258, Zhongyuan Road, Suzhou Jiangsu 215024 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2988-2026 | Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144. | Potential of failing to trigger clinical scan during Bolus Tracking. | Class II | Open, Classified | |
| Z-1003-2026 | Philips Incisive CT | Potential for incomplete scan due to unstable connection inside of floating sensor. | Class II | Open, Classified | |
| Z-0640-2024 | Incisive CT, model 728143 & 728144 running Software Version 5.0.0. | 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 label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP. | Class II | Open, Classified | |
| Z-1273-2021 | Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body. | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain