Automated Breast Ultrasound

Product Code: PAA

Diagnostic Ultrasound Devices

Definition: Adjunct To Mammography For Breast Cancer Screening And Diagnosis.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations:


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as PAA

5446Automated Breast Ultrasound

Total Product Life Cycle (TPLC) Devices

5446Automated Breast Ultrasound

FDA Consensus Standards

Automated Breast Ultrasound [32412]21 CFR Unclassified 🔎
Automated Breast Ultrasound [33222]21 CFR Unclassified 🔎

Pre-market Approvals for PAA

P110006Invenia ABUS 2.0 Automated Breast Ultrasound SystemU-SYSTEMS, INC.

Global Unique Device Identification Database

00840682100090Automated breast ultrasound
00840682141161Automated breast ultrasound
00840682100038Automated Breast Ultrasound
00840682100021Automated Breast Ultrasound
00840682100014Automated Breast Ultrasound
50195594783905Automated breast ultrasound
50195594787279Automated breast ultrasound
00860000221306Automated Breast Ultrasound
50197106192571Automated breast ultrasound
50197106038541Automated breast ultrasound
50197106471607Automated breast ultrasound
50197106493166Automated breast ultrasound
50197106530069Automated breast ultrasound
50197106527342Automated breast ultrasound
50885425282812Automated breast ultrasound

Maude Adverse Events

USYSTEMS INVENIA GEN 2U-SYSTEMS, INC.2018-10-19
INVENIAU-SYSTEMS INC2016-03-03
USYSTEMS INVENIA GEN 2HCS SUNNYVALE2016-02-26
INVENIA SCAN STATION ABUSGE2015-06-30
MAGVIEWMAGVIEW2012-12-19

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