Image Guidance System for Radiotherapy— 510(k) K192405

Substantially Equivalent

Jiangsu Rayer Medical Technology Co., Ltd.

FDA 510(k) clearance K192405 for Image Guidance System for Radiotherapy, Substantially Equivalent on 2020-05-01. Applicant: Jiangsu Rayer Medical Technology Co., Ltd..

Clearance details

Applicant: Jiangsu Rayer Medical Technology Co., Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2019-09-03
Decision date: 2020-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, CN

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.