K231986
- 510(k) number
- K231986
- Device name
- Modus IR
- Applicant
- Synaptive Medical, Inc. CA
- Product code
- IZI — System, X-Ray, Angiographic
- Decision date
- 2024-03-25
- Date received
- 2023-07-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K231986.pdf
Official FDA record: K231986
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.