Digital Radiography System (ManntiX B, ManntiX K)— 510(k) K240841
Substantially EquivalentShenzhen Browiner Tech Co., Ltd.
FDA 510(k) clearance K240841 for Digital Radiography System (ManntiX B, ManntiX K), Substantially Equivalent on 2024-12-09. Applicant: Shenzhen Browiner Tech Co., Ltd..
Clearance details
- Applicant
- Shenzhen Browiner Tech Co., Ltd.
- Product code
- Code IZL
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . 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.