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 Type: Acoustic
• Radition Safety: Abbreviated
• Annual Reports: No

Products Classified as PAA

5446

Automated Breast Ultrasound

Total Product Life Cycle (TPLC) Devices

5446

Automated Breast Ultrasound

FDA Consensus Standards

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

Pre-market Approvals for PAA

P110006

Invenia ABUS 2.0 Automated Breast Ultrasound System

U-SYSTEMS, INC.

Global Unique Device Identification Database

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

Maude Adverse Events

USYSTEMS INVENIA GEN 2	U-SYSTEMS, INC.	2018-10-19
INVENIA	U-SYSTEMS INC	2016-03-03
USYSTEMS INVENIA GEN 2	HCS SUNNYVALE	2016-02-26
INVENIA SCAN STATION ABUS	GE	2015-06-30
MAGVIEW	MAGVIEW	2012-12-19