DeviceClearance

Product code IZH— Radiology

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

Classification name
System, X-Ray, Mammographic
Device class
Class 2
Regulation
21 CFR 892.1710
Advisory panel
Radiology
Total cleared
176
First cleared
Most recent

Market context for product code IZH

FDA has cleared 176 devices under product code IZH between 1977 and 2021, filed by 87 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code IZH

Recent clearances under product code IZH

1–100 of 176

Data sourced from openFDA. This site is unofficial and independent of the FDA.