FDA 510(k)

ATUSA Automated 3D Breast Ultrasound System

K-Number: K213620 · 2022-04-22

Decision Date2022-04-22

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ATUSA Automated 3D Breast Ultrasound System is a medical device manufactured by Isono Health, Inc.. It received FDA 510(k) clearance on 2022-04-22 under approval 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. It is manufactured by Isono Health, Inc.. The 510(k) number is K213620.

When was ATUSA Automated 3D Breast Ultrasound System approved by the FDA?

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

What company makes ATUSA Automated 3D Breast Ultrasound System?

ATUSA Automated 3D Breast Ultrasound System is manufactured by Isono Health, Inc..

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

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

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.