Mobile X-ray unit (!M1)

FDA 510(k) K251710 · Solutions For Tomorrow AB

Substantially Equivalent

510(k) numberK251710

Submission

Device name
Mobile X-ray unit (!M1)
Applicant
Solutions For Tomorrow AB
Väckelsång, SE
Received
June 3, 2025
Decision date
October 24, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IZL – System, X-Ray, Mobile
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1720
Specialty
Radiology

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Questions and answers

When was Mobile X-ray unit (!M1) cleared by the FDA?

Mobile X-ray unit (!M1) (K251710) received a 510(k) decision of Substantially Equivalent on October 24, 2025, 143 days after the submission was received.

What is the product code of K251710?

The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.