Adaptivo— 510(k) K152994

Substantially Equivalent

Aurora Technology Development, LLC

FDA 510(k) clearance K152994 for Adaptivo, Substantially Equivalent on 2016-02-03. Applicant: Aurora Technology Development, LLC.

Clearance details

Applicant: Aurora Technology Development, LLC
Product code: Code IYE
Advisory panel: Radiology
Date received: 2015-10-13
Decision date: 2016-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.