510(k) K251590
K251590 is an FDA 510(k) premarket notification submitted by Methinks Software, S.L for the device "Methinks CTA Stroke". The FDA issued a decision of Substantially Equivalent on August 20, 2025. The device falls under product code QAS (Radiological Computer-Assisted Triage And Notification Software), a Class II device regulated under 21 CFR 892.2080. Methinks Software, S.L has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2025
- Date Received
- May 23, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Computer-Assisted Triage And Notification Software
- Device Class
- Class II
- Regulation Number
- 892.2080
- Review Panel
- RA
- Submission Type
Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification .