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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 K192182
Device Name C015
Micronica SRL
Via Augusto Righi, 30
Mirandola,  IT 41037
Applicant Contact Massimo Tomasi
Thema s.r.l.
Via Saragat,5
Imola,  IT 40026
Correspondent Contact Marisa Testa
Regulation Number892.1650
Classification Product Code
Subsequent Product Codes
Date Received08/12/2019
Decision Date 01/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No