Cleared Traditional

K170607 - !M1

K170607 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 138-day FDA review.

K170607 · Solutions For Tomorrow AB · Radiology device
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Jul 2017
Decision
138d
Days
Class 2
Risk

K170607 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 July 17, 2017 after a review of 138 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K170607

510(k) Number K170607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2017
Decision Date July 17, 2017
Days to Decision 138 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 107d · This submission: 138d
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 131
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K170607.
DRX-Revolution Nano Mobile X-ray System
K173924 · Carestream Health, Inc. · Feb 2018
DRAGON X SPSL4HC, DRAGON X SPSL8HC
K173299 · Sedecal., Sa. · Jan 2018
Optima XR240amx, AutoGrid
K173602 · Ge Medical Systems, LLC · Jan 2018
DRX-Revolution Nano Mobile X-ray System
K170755 · Carestream Health, Inc. · Jun 2017
GM85
K171119 · Samsung Electronics Co., Ltd. · May 2017
FDR AQRO (DR-XD 1000)
K170858 · Fujifilm Medical Systems U.S.A, Inc. · Apr 2017