Spectral CT Verida Family— 510(k) K253649
Substantially EquivalentPhilips Medical Systems Technologies , Ltd.
FDA 510(k) clearance K253649 for Spectral CT Verida Family, Substantially Equivalent on 2026-03-27. Applicant: Philips Medical Systems Technologies , Ltd.. Device class: 2.
Summary
Philips Medical Systems Technologies' Spectral CT Verida Family is filed under JAK, computed tomography x-ray systems. The record doesn't list the individual systems in the family.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Philips Medical Systems Technologies filed from Haifa, Israel. The decision came 127 calendar days after receipt (November 20, 2025 to March 27, 2026).
Clearance details
- Applicant
- Philips Medical Systems Technologies , Ltd.
- Product code
- Product 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
- Haifa, IL
Recent devices under product code JAK
view allMore clearances from Philips Medical Systems Technologies , 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.