Total clearances
4
2024-04-24 → 2026-03-27
Name variants in FDA filings: Philips Medical Systems Technologies / Philips Medical Systems Technologies , Ltd.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| JAK |
System, X-Ray, Tomography, Computed |
Class II |
Radiology |
3 |
2026-03-27 |
| LLZ |
System, Image Processing, Radiological |
Class II |
Radiology |
1 |
2024-04-24 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2024-10-10 |
Class II
|
Ongoing |
Z-0497-2025 |
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is… |
— |
A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Applic… |
Filings
All 510(k) clearances (4)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-03-27 |
K253649 |
Spectral CT Verida Family |
JAK |
Class II |
Radiology |
| 2025-05-16 |
K244008 |
Spectral CT |
JAK |
Class II |
Radiology |
| 2024-10-18 |
K240844 |
Spectral CT 7500 RT |
JAK |
Class II |
Radiology |
| 2024-04-24 |
K240822 |
Image Management V15 |
LLZ |
Class II |
Radiology |