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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K212940
Device Name Skanmobile, Skanmobile-Dr
Applicant
Skanray Technologies Limited
Plot# 15-17, Hebbal Industrial Area, Hebbal
Mysore,  IN 570016
Applicant Contact Vasundhara R
Correspondent
IZiel Healthcare
14, Hadapsar Industrial Estate, Hadapsar
Pune,  IN 411013
Correspondent Contact Ankur Naik
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received09/15/2021
Decision Date 03/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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