SOFTVIEW, MODEL 2.01— 510(k) K092363

Substantially Equivalent

Riverain Medical Group

FDA 510(k) clearance K092363 for SOFTVIEW, MODEL 2.01, Substantially Equivalent on 2010-03-18. Applicant: Riverain Medical Group.

Clearance details

Applicant: Riverain Medical Group
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2009-08-05
Decision date: 2010-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, 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.