510(k) K242499— Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))

Substantially Equivalent

Shenzhen Sontu Medical Imaging Equipment Co., Ltd.

Clearance details

Applicant: Shenzhen Sontu Medical Imaging Equipment Co., Ltd.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2024-08-22
Decision date: 2025-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.