Automated Breast Ultrasound
Device Code: 5446
Product Code(s):
PAA Definition: Adjunct To Mammography For Breast Cancer Screening And Diagnosis.
Device Classification Information
| Device Type ID | 5446 |
| Device Name | Automated Breast Ultrasound |
| Physical State | May Include Different Transducers |
| Technical Method | Uses An Automatic Method Of Acquiring Ultrasound Images Of The Breast |
| Target Area | Breast |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PAA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5446 |
| Device | Automated Breast Ultrasound |
| Product Code | PAA |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems |
|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |
TPLC Last Update: 2019-04-02 21:06:23