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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 the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2021-06-08 under 510(k) 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. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K210458.

When did OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System receive FDA 510(k) clearance?

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

Who is the listed applicant for OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICALK251730LIA Console (542-7)Leadoptik, Inc.K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.K252851deepLive (OSP12 + DMS)Damae MedicalK251198HyperVue™ SoftwareSpectrawave, Inc.K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant

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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