K261037
- 510(k) number
- K261037
- Device name
- 780 nm SPY Portable Handheld Imaging (SPY-PHI) System
- Applicant
- Stryker Endoscopy CA · US
- Product code
- IZI — System, X-Ray, Angiographic
- Decision date
- 2026-05-28
- Date received
- 2026-03-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K261037.pdf
Official FDA record: K261037
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.