Product code IXH— Radiology
MY BREAST FRIEND, BREAST SELF-EXAM PAD
- Classification name
- Camera, Focal Spot, Radiographic
- Device class
- Class 1
- Regulation
- 21 CFR 892.1940
- Advisory panel
- Radiology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code IXH
FDA has cleared devices under product code IXH between 1985 and 2002, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2002
- 1985
Top applicants under product code IXH
Recent clearances under product code IXH
Data sourced from openFDA. This site is unofficial and independent of the FDA.