FDA 510(k)

Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel

N.º K: K173037 · 2017-11-21

Fecha de decisión2017-11-21

Código de productoGEH

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel is the device name listed in this FDA 510(k) record. The listed applicant is Galil Medical, Inc.. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K173037. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel?

Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Galil Medical, Inc.. The 510(k) number is K173037.

When did Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel receive FDA 510(k) clearance?

Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel received FDA 510(k) clearance on 2017-11-21, under 510(k) number K173037.

Who is the listed applicant for Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel?

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

What is the FDA product code for Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel?

The FDA product code for Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel is GEH.

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Otros registros que enlistan a Galil Medical, Inc. como solicitante

K203032IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)K181153ICEfx Cryoablation System

Dispositivos relacionados (Código: GEH)

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH K252198Remover de Manchas de Crioterapia Avanzado (Remover de Manchas de Piel Avanzado)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.

Fuente oficial

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