DELTAVIEW MODEL 2.1— 510(k) K111776

Substantially Equivalent

Riverain Medical Group,Llc

FDA 510(k) clearance K111776 for DELTAVIEW MODEL 2.1, Substantially Equivalent on 2011-12-28. Applicant: Riverain Medical Group,Llc.

Clearance details

Applicant: Riverain Medical Group,Llc
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2011-06-23
Decision date: 2011-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, US

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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.