FDA applicant
Philips Healthcare (Suzhou) Co., Ltd.
FDA records 17 decisions for Philips Healthcare (Suzhou) Co., Ltd. (Suzhou, CN) from 2014 to 2026: 17 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and MOS (Coil, Magnetic Resonance, Specialty). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 121 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 11 of them its own earlier devices. 37 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Philips Healthcare (Suzhou) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2024
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Philips Healthcare (Suzhou) Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report