Spectral CT Verida Family— 510(k) K253649

Substantially Equivalent

Philips 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..

Clearance details

Applicant: Philips Medical Systems Technologies , Ltd.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2025-11-20
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.