Devices · NinePoint Medical, Inc.

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

NinePoint Medical, Inc. is listed for NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (K182616). The FDA list gives November 2, 2018 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code NQQ as “System, Imaging, Optical Coherence Tomography (Oct)”: This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182616

Official FDA database record

Date of final decision

November 2, 2018

Company on the FDA list

NinePoint Medical, Inc.

Lead panel

Radiology

Primary product code

NQQ

openFDA device name for the code

System, Imaging, Optical Coherence Tomography (Oct)

Device class

2

Regulation number

892.1560

openFDA decision description

Unknown

openFDA decision code

SESU

Statement or summary label

Summary