OTE — Digital Breast Tomosynthesis Class III
FDA product code OTE covers "Digital Breast Tomosynthesis", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OTE
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Unknown
- Implant
- No
Definition
To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.