Genesis III (GCFM) Accessory

No FDA recalls on record, checked 6 Oct 2026.

Full name

Accessory to Genesis III (Gcfm)

510(k) Number

K913209 ↗

FDA Product Code

DXK

Device Class

Class II

Regulation

21 CFR Part 870.2330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-A

  Class II

  FDA 510(k) K953530 Active Cleared 8 Apr 1996

• The Galileo Line -- Planet 100, 200 & 300 & Star

  Class II

  FDA 510(k) K923860 Active Cleared 4 Feb 1993

• Artoscan

  Class II

  FDA 510(k) K931022 Active Cleared 7 Oct 1993

• Topographic Brain Mapping Option

  Class II

  FDA 510(k) K934050 Active Cleared 3 Feb 1994

• Genesis II

  Class II

  FDA 510(k) K871697 Active Cleared 6 Nov 1987

• Galileo Evoked Potentialre

  Class II

  FDA 510(k) K963662 Active Cleared 26 Feb 1997

See all devices from Biosound, Inc. →

• What is the Genesis III (GCFM) Accessory designed to improve in echocardiographic imaging, and how does it integrate with existing systems?

  The Genesis III (GCFM) Accessory is specifically designed to enhance imaging capabilities for cardiovascular assessments in echocardiographic systems. As a reusable accessory, it is intended to be used with compatible echocardiographs to improve the quality or clarity of images during cardiac evaluations. It adheres to traditional 510(k) standards and is classified under the Cardiovascular specialty, ensuring compatibility with existing echocardiographic platforms.

• Is the Genesis III (GCFM) Accessory single-use or reusable, and what does this mean for maintenance and cost?

  The Genesis III (GCFM) Accessory is explicitly described as a reusable device. This means it is intended for repeated use across multiple patients, which can reduce ongoing costs compared to single-use accessories. However, it also requires proper cleaning, sterilization, and maintenance protocols to ensure safety and performance over time, as outlined in the manufacturer’s instructions.

• How was the Genesis III (GCFM) Accessory evaluated for regulatory approval, and what does its classification under product code DXK imply?

  The Genesis III (GCFM) Accessory underwent a traditional 510(k) review process, where it was determined to be substantially equivalent to predicate devices already on the market. The product code DXK under FDA regulation 870.2330 categorizes it as an accessory for echocardiographs, confirming its role in enhancing diagnostic imaging for cardiovascular assessments. The clearance was granted in 1992, reflecting its long-standing use in clinical settings.

• What should clinicians or facilities consider when storing or handling the Genesis III (GCFM) Accessory to ensure optimal performance?

  While specific storage instructions aren’t detailed in the provided data, the accessory’s reusable nature implies it must be stored in a clean, dry environment to prevent contamination or damage. Facilities should follow Biosound’s guidelines for cleaning, sterilization, and maintenance to preserve functionality and compliance with clinical standards. Proper handling ensures longevity and reliability during repeated use with echocardiographic systems.