Cleared Traditional

!M1

K241980 · Solutions For Tomorrow AB · Radiology

May 2025

Decision

305d

Days

Class 2

Risk

About This 510(k) Submission

K241980 is an FDA 510(k) clearance for the !M1, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Solutions For Tomorrow AB (Vackelsang, SE). The FDA issued a Cleared decision on May 6, 2025, 305 days after receiving the submission on July 5, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K241980 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2024
Decision Date	May 06, 2025
Days to Decision	305 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF