K242239
- 510(k) number
- K242239
- Device name
- HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
- Applicant
- Gentuity, LLC MA · US
- Product code
- NQQ — System, Imaging, Optical Coherence Tomography (Oct)
- Decision date
- 2024-08-16
- Date received
- 2024-07-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K242239.pdf
Official FDA record: K242239
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.