DuraDiagnost— 510(k) K201640
Substantially EquivalentPhilips Healthcare (Suzhou) Co., Ltd.
FDA 510(k) clearance K201640 for DuraDiagnost, Substantially Equivalent on 2020-07-09. Applicant: Philips Healthcare (Suzhou) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Philips Healthcare (Suzhou) Co., Ltd.
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Suzhou, CN
Recent devices under product code KPR
view allMore clearances from Philips Healthcare (Suzhou) Co., Ltd.
view allAdverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K201640
K-number listed on FDA's recall record- Z-1553-2025 — Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
- Z-1554-2025 — Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201640.
Data sourced from openFDA. This site is unofficial and independent of the FDA.