K252526
- 510(k) number
- K252526
- Device name
- Rapid DeltaFuse
- Applicant
- Ischemaview, Inc. CO · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-08-26
- Date received
- 2025-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K252526.pdf
Official FDA record: K252526
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.