AlignRT Plus (8.0)— 510(k) K253012

Substantially Equivalent

Vision Rt, Ltd.

FDA 510(k) clearance K253012 for AlignRT Plus (8.0), Substantially Equivalent on 2026-03-18. Applicant: Vision Rt, Ltd..

Clearance details

Applicant: Vision Rt, Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2025-09-19
Decision date: 2026-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

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.