510(k) · Radiology

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

by Abbott Medical

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System is an AI-enabled medical device from Abbott Medical that the U.S. FDA cleared through 510(k) K210458 on June 8, 2021. 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 2021, all FDA AI clearances in 2021, top radiology AI devices.

Key facts

Submission numberK210458
Pathway510(k)
Date of final decision
Company (FDA list)Abbott Medical
Lead review panelRadiology
Primary product codeNQQ — System, Imaging, Optical Coherence Tomography (Oct)
Applicant (openFDA)ABBOTT MEDICAL
Applicant locationWestford, MA, US
Device classClass 2
Regulation number21 CFR 892.1560
Decision codeSESE
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. OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System went through this pathway (K210458).

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 #3 of 4 under that code. Abbott Medical has 3 AI-enabled devices 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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