510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PAAClass III

Automated Breast Ultrasound

Unknown
FDA source (opens on fda.gov)

PAA is the FDA product code for Automated Breast Ultrasound, a class III device type. FDA's definition for this code reads: "Adjunct to mammography for breast cancer screening and diagnosis". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
PAA
Device name
Automated Breast Ultrasound
FDA definition
Adjunct to mammography for breast cancer screening and diagnosis.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code