Rover— 510(k) K211423

Substantially Equivalent

Micro-X Limited

FDA 510(k) clearance K211423 for Rover, Substantially Equivalent on 2021-05-21. Applicant: Micro-X Limited.

Clearance details

Applicant: Micro-X Limited
Product code: Code IZL
Advisory panel: Radiology
Date received: 2021-05-07
Decision date: 2021-05-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Cloverly Park, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.