K243378
- 510(k) number
- K243378
- Device name
- Rapid MLS
- Applicant
- Ischemaview, Inc. CO · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-05-28
- Date received
- 2024-10-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243378.pdf
Official FDA record: K243378
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.