K243645
- 510(k) number
- K243645
- Device name
- IC-Flow Imaging System 2.0
- Applicant
- Diagnostic Green GmbH DE
- Product code
- IZI — System, X-Ray, Angiographic
- Decision date
- 2025-09-22
- Date received
- 2024-11-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243645.pdf
Official FDA record: K243645
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.