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FDA 510(k)

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

Número K: K203578 · 2021-02-25

RequerentePerimeter Medical Imaging Ai, Inc.
Data da decisão2021-02-25
Código do produtoNQQ
Comité consultivoRA
DecisãoSubstantially Equivalent

Resumo do dispositivo

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is the device name listed in this FDA 510(k) record. The listed applicant is Perimeter Medical Imaging Ai, Inc.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K203578. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System?

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Perimeter Medical Imaging Ai, Inc.. The 510(k) number is K203578.

When did OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System receive FDA 510(k) clearance?

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System received FDA 510(k) clearance on 2021-02-25, under 510(k) number K203578.

Who is the listed applicant for OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System?

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

What is the FDA product code for OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System?

The FDA product code for OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is NQQ.

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