510(k) K172404
K172404 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "SenoBright HD". The FDA issued a decision of Substantially Equivalent on Oct 30, 2017. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. GE Healthcare has 168 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 30, 2017
- Date Received
- Aug 9, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Full Field Digital, System, X-Ray, Mammographic
- Device Class
- Class II
- Regulation Number
- 892.1715
- Review Panel
- RA
- Submission Type
- 510(k)