MX40 Mobile Digital X-ray System— 510(k) K181874
Substantially EquivalentHuestis Machine Corporation
FDA 510(k) clearance K181874 for MX40 Mobile Digital X-ray System, Substantially Equivalent on 2018-09-14. Applicant: Huestis Machine Corporation.
Clearance details
- Applicant
- Huestis Machine Corporation
- Product code
- Code IZL
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bristol, RI, US
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.