K251650
- 510(k) number
- K251650
- Device name
- Insight Enhanced DRF (EN-1002-01)
- Applicant
- Imaging Engineering, LLC FL · US
- Product code
- JAA — System, X-Ray, Fluoroscopic, Image-Intensified
- Decision date
- 2025-09-16
- Date received
- 2025-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251650.pdf
Official FDA record: K251650
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.