Philips Incisive CT— 510(k) K212441
Substantially EquivalentPhilips Healthcare (Suzhou) Co., Ltd.
FDA 510(k) clearance K212441 for Philips Incisive CT, Substantially Equivalent on 2022-04-27. Applicant: Philips Healthcare (Suzhou) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Philips Healthcare (Suzhou) Co., Ltd.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code JAK
view allMore clearances from Philips Healthcare (Suzhou) Co., Ltd.
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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 K212441
K-number listed on FDA's recall record- Z-2988-2026 — Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
- Z-1003-2026 — Philips Incisive CT
- Z-0881-2026 — Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
- Z-0375-2026 — Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
- Z-0376-2026 — Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
- Z-0377-2026 — Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
- Z-1872-2024 — Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
- Z-0719-2024 — Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
- Z-2520-2023 — Incisive CT, software version 5.0
- Z-1622-2023 — Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
- Z-1623-2023 — Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
- Z-1624-2023 — Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
- Z-1625-2023 — Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
- Z-1585-2023 — Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
- Z-1586-2023 — Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
- Z-0640-2024 — Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
- Z-0576-2024 — The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212441.
Data sourced from openFDA. This site is unofficial and independent of the FDA.