MRCP+ version 2 (MRCP+ v2)— 510(k) K233930

Substantially Equivalent

Perspectum

FDA 510(k) clearance K233930 for MRCP+ version 2 (MRCP+ v2), Substantially Equivalent on 2024-03-13. Applicant: Perspectum.

Clearance details

Applicant: Perspectum
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2023-12-14
Decision date: 2024-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

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.