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FDA 510(k)

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

K-Number: K210458 · 2021-06-08

ApplicantABBOTT MEDICAL
Decision Date2021-06-08
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2021-06-08 under approval number K210458. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System?

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System is a medical device that received FDA 510(k) clearance on 2021-06-08. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K210458.

When was OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System approved by the FDA?

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System received FDA 510(k) clearance on 2021-06-08, under approval number K210458.

What company makes OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System?

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System is manufactured by ABBOTT MEDICAL.

What is the FDA product code for OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System?

The FDA product code for OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System is NQQ.

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Related Devices (Code: NQQ)

K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd. K153283VivoSight Dx Topical OCT SystemMichelson Diagnostics, Ltd. K160878OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc. K160240Perimeter Otis™ 1.0 Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation SystemNinepoint Medical, Inc. K171560OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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