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FDA 510(k)

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit

N.º K: K182276 · 2018-11-01

SolicitanteBayer Medical Care, Inc.
Fecha de decisión2018-11-01
Código de productoDXT
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K182276. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit?

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K182276.

When did MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit receive FDA 510(k) clearance?

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit received FDA 510(k) clearance on 2018-11-01, under 510(k) number K182276.

Who is the listed applicant for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit?

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

What is the FDA product code for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit?

The FDA product code for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is DXT.

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Otros registros que enlistan a Bayer Medical Care, Inc. como solicitante

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K253688MEDRAD® Imaging Bulk Package Transfer SpikeK252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)K250893Ball Joint Guide Array (66295)K200280MEDRAD Imaging Bulk Package Transfer SpikeK192370MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationK193028MEDRAD Mark 7 Arterion Injection System

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: DXT)

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.

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company LimitedK252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)Acist Medical Systems, Inc.K252653Sistema de Diagnóstico ACIST Pro (019304); Unidad de Procesamiento Montada en Cama; Módulo AngioTouch; Carro ACIST Pro; Cable de Transductor Único; Cable de Transductor TripleAcist Medical Systems, Inc.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc.

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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