← FDA Medical Device Classifications
Cross-Sectional Mammographic Xray System
OLQ · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
- FDA Product Code
OLQ- 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
Diagnostic breast imaging. Imaging of the breast by cross-sectional x-ray imaging for diagnostic purposes.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown