SmartCeph— 510(k) K190162

Substantially Equivalent

Ortho2, LLC

FDA 510(k) clearance K190162 for SmartCeph, Substantially Equivalent on 2019-10-17. Applicant: Ortho2, LLC.

Clearance details

Applicant: Ortho2, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2019-01-31
Decision date: 2019-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ames, IA, 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.