Devices · Abbott Medical

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

Abbott Medical is listed for OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System (K210458). The FDA list gives June 8, 2021 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 “Substantially Equivalent.” 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=K210458

Official FDA database record

Date of final decision

June 8, 2021

Company on the FDA list

Abbott Medical

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

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary