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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name full field digital, system, x-ray, mammographic
510(k) Number K202822
Device Name Helianthus
Metaltronica Spa
66 via delle Monachelle
Pomezia RM,  IT CAP 00071
Applicant Contact Gloria Pesce Delfino
Emergo Europe Consulting
Prinsessegracht 20
The Hague,  NL 2514AP
Correspondent Contact Rachel Paul
Regulation Number892.1715
Classification Product Code
Date Received09/24/2020
Decision Date 12/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No