Cleared Traditional

Skanmobile, Skanmobile-Dr

K212940 · Skanray Technologies Limited · Radiology

Mar 2022

Decision

170d

Days

Class 2

Risk

About This 510(k) Submission

K212940 is an FDA 510(k) clearance for the Skanmobile, Skanmobile-Dr, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Skanray Technologies Limited (Mysore, IN). The FDA issued a Cleared decision on March 4, 2022, 170 days after receiving the submission on September 15, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K212940 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2021
Decision Date	March 04, 2022
Days to Decision	170 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF