SUITEHEART— 510(k) K130228

Substantially Equivalent

Neosoft, LLC

FDA 510(k) clearance K130228 for SUITEHEART, Substantially Equivalent on 2013-03-20. Applicant: Neosoft, LLC.

Clearance details

Applicant: Neosoft, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-01-29
Decision date: 2013-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pewaukee, WI, US

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.