510(k) · Radiology

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

by NinePoint Medical, Inc.

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System is an AI-enabled medical device from NinePoint Medical, Inc. that the U.S. FDA cleared through 510(k) K182616 on November 2, 2018. Its lead review panel is Radiology and its primary product code is NQQ (System, Imaging, Optical Coherence Tomography (Oct)).

See also FDA-cleared AI radiology devices in 2018, all FDA AI clearances in 2018, top radiology AI devices.

Key facts

Submission numberK182616
Pathway510(k)
Date of final decision
Company (FDA list)NinePoint Medical, Inc.
Lead review panelRadiology
Primary product codeNQQ — System, Imaging, Optical Coherence Tomography (Oct)
Applicant (openFDA)Ninepoint Medical, Inc.
Applicant locationBedford, MA, US
Device classClass 2
Regulation number21 CFR 892.1560
Decision codeSESU
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System went through this pathway (K182616).

openFDA lists it as a Class 2 device under 21 CFR 892.1560. Class II devices are moderate risk and are subject to general and special controls.

Product code NQQ covers 4 devices on the FDA AI list. By decision date, this device is #1 of 4 under that code. NinePoint Medical, Inc. has 1 AI-enabled device on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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