Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Philips Healthcare (Suzhou) Co., Ltd. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
260 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 | 186 | 0 |
| K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-20 | 31 | 0 |
| K242329 | CT Collaboration Live | Philips Healthcare (Suzhou) Co., Ltd. | 2024-11-18 | 104 | 0 |
| K232491 | CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. | 2024-05-03 | 260 | 5 |
| K233600 | Smart Fit Knee 3.0T | Philips Healthcare (Suzhou) Co., Ltd. | 2024-02-05 | 88 | 0 |
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2023-09-01 | 56 | 0 |
| K223311 | Philips CT 3500 | Philips Healthcare (Suzhou) Co., Ltd. | 2022-12-22 | 55 | 0 |
| K212441 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | 2022-04-27 | 266 | 16 |
| K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2021-12-01 | 84 | 0 |
| K211168 | Philips Incisive CT on Trailer | Philips Healthcare (Suzhou) Co., Ltd. | 2021-11-22 | 217 | 1 |
| K203514 | Precise Position | Philips Healthcare (Suzhou) Co., Ltd. | 2021-06-17 | 199 | 0 |
| K201640 | DuraDiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2020-07-09 | 23 | 2 |
| K191136 | Access CT | Philips Healthcare (Suzhou) Co., Ltd. | 2019-07-29 | 91 | 0 |
| K173507 | Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 | Philips Healthcare (Suzhou) Co., Ltd. | 2018-06-15 | 214 | 0 |
| K180015 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | 2018-03-20 | 77 | 21 |
| K163410 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Ltd. | 2017-01-04 | 30 | 3 |
| K141381 | DURADIAGNOST | Philips Healthcare (Suzhou) Co., Ltd. | 2014-06-12 | 16 | 6 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda