Brainreader ApS
FDA Regulatory Profile
Brainreader ApS appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0934-2021, Class II) was initiated on December 14, 2020. Its most recent 510(k) clearance was granted on February 4, 2015.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0934-2021 | Class II | Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manu | December 14, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140828 | NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE | February 4, 2015 |