Cardiac Review Station

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K812515 ↗

FDA Product Code

DXG

Device Class

Class II

Regulation

21 CFR Part 870.1435

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Digital Flurographic Imaging System

  Class II

  FDA 510(k) K813217 Active Cleared 29 Dec 1981

• Cw Doppler 2.25 Mhz Probe

  Class II

  FDA 510(k) K903562 Active Cleared 2 Mar 1992

• Diasonics Drf-200 Ultrasound Imaging System

  Class II

  FDA 510(k) K851860 Active Cleared 31 Oct 1985

• Diasonics, Berger Stereotactic Neorobiopsy

  Class II

  FDA 510(k) K851973 Active Cleared 26 Jul 1985

• Adms Transrectal 7.5 Mhz Probe

  Class II

  FDA 510(k) K870967 Active Cleared 29 Sep 1987

• Cfm-800 Color Flow Mapping System

  Class II

  FDA 510(k) K924079 Active Cleared 28 Sep 1993

See all devices from Diasonics, Inc. →