510(k) K253421— Perfusion Measurement Platform v1

Substantially Equivalent

Quantified Imaging Limited

Clearance details

Applicant: Quantified Imaging Limited
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2025-10-01
Decision date: 2026-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.