Cleared Traditional

Mobile X-ray unit (!M1)

K251710 · Solutions For Tomorrow AB · Radiology

Oct 2025

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K251710 is an FDA 510(k) clearance for the Mobile X-ray unit (!M1), a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Solutions For Tomorrow AB (V?ckels?ng, SE). The FDA issued a Cleared decision on October 24, 2025, 143 days after receiving the submission on June 3, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K251710 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2025
Decision Date	October 24, 2025
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF