Cleared Traditional

!M1

K170607 · Solutions For Tomorrow AB · Radiology

Jul 2017

Decision

138d

Days

Class 2

Risk

About This 510(k) Submission

K170607 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 July 17, 2017, 138 days after receiving the submission on March 1, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K170607 FDA.gov
FDA Decision	Cleared 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