K243077
- 510(k) number
- K243077
- Device name
- Affirm 800
- Applicant
- Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) CA · US
- Product code
- IZI — System, X-Ray, Angiographic
- Decision date
- 2025-06-27
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243077.pdf
Official FDA record: K243077
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.