510(k) K211279
K211279 is an FDA 510(k) premarket notification submitted by Volpara Health Technologies Limited for the device "Volpara Imaging Software". The FDA issued a decision of Substantially Equivalent on Jul 27, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Volpara Health Technologies Limited has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 27, 2021
- Date Received
- Apr 27, 2021
- Clearance Type
- Special
- 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)