K232156
- 510(k) number
- K232156
- Device name
- Rapid ASPECTS (v3)
- Applicant
- Ischemaview, Inc. CO · US
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2024-01-19
- Date received
- 2023-07-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K232156.pdf
Official FDA record: K232156
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.