Rapid Vessel Occlusion (Rapid VO)— 510(k) K261085
Substantially EquivalentiSchemaview
FDA 510(k) clearance K261085 for Rapid Vessel Occlusion (Rapid VO), Substantially Equivalent on 2026-07-13. Applicant: iSchemaview. Device class: 2.
Summary
iSchemaview's Rapid Vessel Occlusion (Rapid VO) is filed under QAS, radiological computer-assisted triage and notification software. The record doesn't describe the software's inputs or outputs.
Class II, 21 CFR 892.2080. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
iSchemaview filed from Golden, Colorado. The decision came 103 calendar days after receipt (April 1 to July 13, 2026).
Clearance details
- Applicant
- iSchemaview
- Product code
- Product code QAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Golden, CO, US
Recent devices under product code QAS
view allMore clearances from iSchemaview
view allData sourced from openFDA. This site is unofficial and independent of the FDA.