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FDA 510(k)

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

N.º K: K203578 · 2021-02-25

SolicitantePerimeter Medical Imaging Ai, Inc.
Fecha de decisión2021-02-25
Código de productoNQQ
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: NQQ)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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