ATUSA™ Automated 3D Breast Ultrasound System

System, Imaging, Pulsed Echo, Ultrasonic

ISono Health, Inc.

The following data is part of a premarket notification filed by Isono Health, Inc. with the FDA for Atusa™ Automated 3d Breast Ultrasound System.

Pre-market Notification Details

Device IDK213620
510k NumberK213620
Device Name:ATUSA™ Automated 3D Breast Ultrasound System
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant iSono Health, Inc. 395 Oyster Point Blvd., Suite 501 South San Fransisco,  CA  94080
ContactShadi Saberi
CorrespondentDaniel Lehtonen
Compliance And Regulatory Services LLC 3771 Southbrook Dr Dayton,  OH  45430
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-16
Decision Date2022-04-22

Trademark Results [ATUSA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ATUSA
ATUSA
88369099 not registered Live/Pending
ISONO HEALTH, INC.
2019-04-03

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