510(k) K140828
K140828 is an FDA 510(k) premarket notification submitted by Brainreader Aps for the device "NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE". The FDA issued a decision of Substantially Equivalent on February 4, 2015. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2015
- Date Received
- April 1, 2014
- Clearance Type
- Traditional
- 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