510(k) K190575
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2019
- Date Received
- March 6, 2019
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Documentation, Breast Lesion
- Device Class
- Class II
- Regulation Number
- 884.2990
- Review Panel
- OB
- Submission Type
A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.