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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 the device name listed in this FDA 510(k) record. The listed applicant is Solutions For Tomorrow AB. It received FDA 510(k) clearance on 2025-10-24 under 510(k) 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. The listed applicant is Solutions For Tomorrow AB. The 510(k) number is K251710.

When did Mobile X-ray unit (!M1) receive FDA 510(k) clearance?

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

Who is the listed applicant for Mobile X-ray unit (!M1)?

The FDA 510(k) record lists Solutions For Tomorrow AB as the applicant. This does not by itself establish the device manufacturer.

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 records listing Solutions For Tomorrow AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241980!M1K170607!M1

Related Devices (Code: IZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

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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