Cleared Traditional

K241980 - !M1

K241980 is an FDA 510(k) clearance for !M1, manufactured by Solutions For Tomorrow AB. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K241980 · Solutions For Tomorrow AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
305d
Days
Class 2
Risk

K241980 is an FDA 510(k) clearance for the !M1. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Solutions For Tomorrow AB (Vackelsang, SE). The FDA issued a Cleared decision on May 6, 2025 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Solutions For Tomorrow AB devices

FDA 510(k) Submission Details - K241980

510(k) Number K241980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 107d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZL System, X-ray, Mobile

All 130
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