510(k) DEN020001
DEN020001 is an FDA 510(k) premarket notification submitted by Assurance Medical for the device "BREASTVIEW VISUAL MAPPING SYSTEM". The FDA issued a decision of De Novo Granted on January 31, 2003. The device falls under product code NKA (System, Documentation, Breast Lesion), a Class II device regulated under 21 CFR 884.2990.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 31, 2003
- Date Received
- May 28, 2002
- Clearance Type
- Post-NSE
- 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.