510(k) K182616
K182616 is an FDA 510(k) premarket notification submitted by Ninepoint Medical, Inc. for the device "NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System". The FDA issued a decision of SESU on November 2, 2018. The device falls under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)), a Class II device regulated under 21 CFR 892.1560. Ninepoint Medical, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- November 2, 2018
- Date Received
- September 21, 2018
- Clearance Type
- Traditional
- 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.