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FDA 510(k)

ATUSA™ Automated 3D Breast Ultrasound System

K-Number: K213620 · 2022-04-22

ApplicantIsono Health, Inc.
Decision Date2022-04-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ATUSA™ Automated 3D Breast Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Isono Health, Inc.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K213620. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATUSA™ Automated 3D Breast Ultrasound System?

ATUSA™ Automated 3D Breast Ultrasound System is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Isono Health, Inc.. The 510(k) number is K213620.

When did ATUSA™ Automated 3D Breast Ultrasound System receive FDA 510(k) clearance?

ATUSA™ Automated 3D Breast Ultrasound System received FDA 510(k) clearance on 2022-04-22, under 510(k) number K213620.

Who is the listed applicant for ATUSA™ Automated 3D Breast Ultrasound System?

The FDA 510(k) record lists Isono Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATUSA™ Automated 3D Breast Ultrasound System?

The FDA product code for ATUSA™ Automated 3D Breast Ultrasound System is IYO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07505797ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)RECRUITING

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.K253714IntraSight PlusPhilips Image Guided Therapy Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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