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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K251893
Device Name SKAN C PULSAR
Applicant
Skanray Technologies Limited
Plot# 15-17, Hebbal Industrial Area
Mysore,  IN 570016
Applicant Contact Vasundhara R
Correspondent
Skanray Technologies Limited
Plot# 15-17, Hebbal Industrial Area
Mysore,  IN 570016
Correspondent Contact Vasundhara R
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received06/20/2025
Decision Date 12/16/2025
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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