Perfusion Measurement Platform v1— 510(k) K253421

Name: FDA 510(k) clearance K253421
Creator: U.S. Food and Drug Administration
Published: 2026-06-22

Substantially Equivalent

Quantified Imaging Limited

FDA 510(k) clearance K253421 for Perfusion Measurement Platform v1, Substantially Equivalent on 2026-06-22. Applicant: Quantified Imaging Limited. Device class: 2.

Summary

Quantified Imaging's Perfusion Measurement Platform v1 is filed under LLZ, radiological image processing systems. The name points to perfusion measurement, but the record doesn't describe the inputs or outputs.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. The submission was a Traditional 510(k).

Quantified Imaging filed from London, United Kingdom. Review took 264 calendar days (October 1, 2025 to June 22, 2026).

Clearance details

Applicant: Quantified Imaging Limited
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-10-01
Decision date: 2026-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

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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.