UniSyn Molecular Imaging (6-3-1)— 510(k) K231047

Substantially Equivalent

Convergent Imaging Solutions

FDA 510(k) clearance K231047 for UniSyn Molecular Imaging (6-3-1), Substantially Equivalent on 2023-09-01. Applicant: Convergent Imaging Solutions.

Clearance details

Applicant: Convergent Imaging Solutions
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2023-04-12
Decision date: 2023-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

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.