K261132
- 510(k) number
- K261132
- Device name
- Healium Intelliscan LX192LC
- Applicant
- Healium Intelliscan Corporation NY · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-05-05
- Date received
- 2026-04-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261132.pdf
Official FDA record: K261132
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.