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. Device class: 2.

Clearance details

Applicant
Perspectum
Product code
Code LLZ
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Oxford, GB
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

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.