← FDA Medical Device Classifications
Digital Breast Tomosynthesis
OTE · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
- FDA Product Code
OTE- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- —
- Review panel
- RA
- Medical specialty
- Unknown
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 20
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown