510(k) K172027
K172027 is an FDA 510(k) premarket notification submitted by Adani for the device "Adani MammoScan". The FDA issued a decision of Substantially Equivalent on Oct 20, 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. Adani has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 20, 2017
- Date Received
- Jul 5, 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)