Mobile X-ray unit (!M1)— 510(k) K251710

Substantially Equivalent

Solutions For Tomorrow AB

FDA 510(k) clearance K251710 for Mobile X-ray unit (!M1), Substantially Equivalent on 2025-10-24. Applicant: Solutions For Tomorrow AB.

Clearance details

Applicant
Solutions For Tomorrow AB
Product code
Code IZL
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Väckelsång, SE
Download summary PDFView on FDA.gov ↗

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.