Device type
Digital Breast Tomosynthesis
Product code OTE · Class III · Unknown
To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Recent 510(k)s
No 510(k) clearances in the archive for OTE.
Recent recalls
Nov 4, 2026
Z-0328-2027
Senographe Pristina 3D
GE Medical Systems, LLC
- OTE
- Class III
- Open, Classified