510(k) K152009
K152009 is an FDA 510(k) premarket notification submitted by Statlife for the device "DENSEEMAMMO v1.0". The FDA issued a decision of Substantially Equivalent on Dec 5, 2016. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Statlife has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 5, 2016
- Date Received
- Jul 21, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)