FDA product code PAA: Automated Breast Ultrasound
PAA is the FDA product code for automated breast ultrasound. It is a Class III device, reviewed by the Radiology panel. Devices under PAA reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 1 recall for PAA devices.
Definition
Adjunct to mammography for breast cancer screening and diagnosis.
Classification
| Field | Value |
|---|---|
| Device name | Automated Breast Ultrasound |
| Device class | Class III |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PAA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-05-16.
Frequently asked questions
What is FDA product code PAA?
PAA is the FDA product code for automated breast ultrasound. It is a Class III device, reviewed by the Radiology panel.
What device class is PAA?
Class III. Typical premarket route: PMA.
Have PAA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-05-16.
Next steps
- Run an FDA pathway report with predicate devices for product code PAA
- Run a recall and safety report across every PAA manufacturer
- Watch product code PAA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.