510(k) K202822
K202822 is an FDA 510(k) premarket notification submitted by Metaltronica Spa for the device "Helianthus". The FDA issued a decision of Substantially Equivalent on December 15, 2021. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2021
- Date Received
- September 24, 2020
- 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