510(k) clearance
Rapid ICH (v4.0)
- 510(k) number
- K262301
- Applicant
- Ischemaview, Inc.
- Decision date
- Oct 9, 2026
- Date received
- Jul 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QAS
- Device type
- Radiological Computer-Assisted Triage And Notification Software
- Device class
- Class II
- Regulation
- 21 CFR 892.2080
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Golden, CO, US