Digital Breast Tomosynthesis
The Digital Breast Tomosynthesis (product code OTE) is an advanced mammography system that generates digital 3D mammographic images used for the screening and diagnosis of breast cancer. Unlike conventional 2D mammography, tomosynthesis acquires multiple X-ray images at different angles to reconstruct a three-dimensional image of the breast, improving lesion detection and characterization. As an FDA Class 3 device without an assigned regulation number, it requires Premarket Approval (PMA) to demonstrate safety and effectiveness, and is reviewed by the Radiology panel. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OTE
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- RA
- Submission Type
- 2
Device Characteristics
Definition
To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
FEI Numbers
This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.