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PAA — Automated Breast Ultrasound Class III

FDA Device Classification

FDA product code PAA covers "Automated Breast Ultrasound", a Class III medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code: PAA
Device Class: Class III
Regulation Number
Submission Type
Review Panel: RA
Medical Specialty: Unknown
Implant: No

Definition

Adjunct to mammography for breast cancer screening and diagnosis.