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FDA 510(k)

Mobile X-ray unit (!M1)

K-Number: K251710 · 2025-10-24

ApplicantSolutions For Tomorrow AB
Decision Date2025-10-24
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mobile X-ray unit (!M1) is a medical device manufactured by Solutions For Tomorrow AB. It received FDA 510(k) clearance on 2025-10-24 under approval number K251710. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mobile X-ray unit (!M1)?

Mobile X-ray unit (!M1) is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Solutions For Tomorrow AB. The 510(k) number is K251710.

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

Mobile X-ray unit (!M1) received FDA 510(k) clearance on 2025-10-24, under approval number K251710.

What company makes Mobile X-ray unit (!M1)?

Mobile X-ray unit (!M1) is manufactured by Solutions For Tomorrow AB.

What is the FDA product code for Mobile X-ray unit (!M1)?

The FDA product code for Mobile X-ray unit (!M1) is IZL.

Other Devices by Solutions For Tomorrow AB

K170607!M1 K241980!M1

Related Devices (Code: IZL)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. K162687Paragon 2Meridian Medical Systems, LLC K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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