CT 5300— 510(k) K232491
Substantially EquivalentPhilips Healthcare (Suzhou) Co., Ltd.
FDA 510(k) clearance K232491 for CT 5300, Substantially Equivalent on 2024-05-03. 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 K232491
K-number listed on FDA's recall record- Z-0881-2026 — Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
- Z-0882-2026 — CT 5300; 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;
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232491.
Data sourced from openFDA. This site is unofficial and independent of the FDA.