Arterys Software v2.0— 510(k) K162513

Substantially Equivalent

Arterys, Inc.

FDA 510(k) clearance K162513 for Arterys Software v2.0, Substantially Equivalent on 2016-10-28. Applicant: Arterys, Inc..

Clearance details

Applicant: Arterys, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-09-08
Decision date: 2016-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, 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.