510(k) K220149— General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)

Substantially Equivalent

Xera Medical Systems & Technology , Ltd.

Clearance details

Applicant: Xera Medical Systems & Technology , Ltd.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2022-01-19
Decision date: 2022-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ankara, TR

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.