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FDA 510(k)

OTIS Optical Coherence Tomography SYstem

K-Number: K190404 · 2019-03-26

ApplicantPerimeter Medical Imaging, Inc.
Decision Date2019-03-26
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OTIS Optical Coherence Tomography SYstem is the device name listed in this FDA 510(k) record. The listed applicant is Perimeter Medical Imaging, Inc.. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K190404. 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 OTIS Optical Coherence Tomography SYstem?

OTIS Optical Coherence Tomography SYstem is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Perimeter Medical Imaging, Inc.. The 510(k) number is K190404.

When did OTIS Optical Coherence Tomography SYstem receive FDA 510(k) clearance?

OTIS Optical Coherence Tomography SYstem received FDA 510(k) clearance on 2019-03-26, under 510(k) number K190404.

Who is the listed applicant for OTIS Optical Coherence Tomography SYstem?

The FDA 510(k) record lists Perimeter Medical Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTIS Optical Coherence Tomography SYstem?

The FDA product code for OTIS Optical Coherence Tomography SYstem is NQQ.

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Other records listing Perimeter Medical Imaging, Inc. as applicant

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.

K171560OTIS Optical Coherence Tomography SystemK160240Perimeter Otis™ 1.0 Optical Coherence Tomography System

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

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

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