510(k) K242239
K242239 is an FDA 510(k) premarket notification submitted by Gentuity, LLC for the device "HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))". The FDA issued a decision of Substantially Equivalent on August 16, 2024. The device falls under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)), a Class II device regulated under 21 CFR 892.1560. Gentuity, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2024
- Date Received
- July 30, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Optical Coherence Tomography (Oct)
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- SU
- Submission Type
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.