FDA 510(k)

Sistema de Diagnóstico ACIST Pro (019304); Unidad de Procesamiento Montada en Cama; Módulo AngioTouch; Carro ACIST Pro; Cable de Transductor Único; Cable de Transductor Triple

N.º K: K252653 · 2026-05-13

Fecha de decisión2026-05-13

Código de productoDXT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable is the device name listed in this FDA 510(k) record. The listed applicant is Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-05-13 under 510(k) number K252653. 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 ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable?

ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable is a medical device that received FDA 510(k) clearance on 2026-05-13. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K252653.

When did ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable receive FDA 510(k) clearance?

ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable received FDA 510(k) clearance on 2026-05-13, under 510(k) number K252653.

Who is the listed applicant for ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable?

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

What is the FDA product code for ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable?

The FDA product code for ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable is DXT.

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Otros registros que enlistan a Acist Medical Systems, Inc. como solicitante

K262115VueJect® Ultrasound Enhancing Agent Delivery System K252638VeraPro 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)K233904Sistema RXi ACIST (016616); Catéter Navvus II ACIST (016675_)K203004Sistema de Entrega de Contraste ACIST CVi1, Sistema de Entrega de Contraste ACIST CVi K193183Sistema ACIST HDi, Catéter de Ultrasonido Intravascular ACIST Kodama K190473Sistema RXi ACIST y Catéter Navvus II

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: DXT)

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 Limited K252638VeraPro 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.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.K244038High Pressure TubingShandong Int Medical Instruments Co., Ltd.

Fuente oficial

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