OnePacs System— 510(k) K181460

Substantially Equivalent

Onepacs, LLC

FDA 510(k) clearance K181460 for OnePacs System, Substantially Equivalent on 2018-10-11. Applicant: Onepacs, LLC.

Clearance details

Applicant: Onepacs, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2018-06-04
Decision date: 2018-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, 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.