Echocardiography System Series 95000

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K992259 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Diskcam Dc 6001

  Class I

  FDA 510(k) K884148 Active Cleared 23 Nov 1988

• Video Plus System, Series 95000

  Class II

  FDA 510(k) K992666 Active Cleared 13 Oct 1999

• Digital Imaging System

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  FDA 510(k) K954159 Active Cleared 19 Mar 1996

• CCD Camera Model 9000

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  FDA 510(k) K990066 Active Cleared 17 Mar 1999

• Multicam I 8X10

  Class II

  FDA 510(k) K912341 Active Cleared 26 Aug 1991

• Color Diskstore

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  FDA 510(k) K922647 Active Cleared 11 Aug 1992

See all devices from Camtronics, Ltd. →

• What is the Echocardiography System Series 95000 used for?

  The system is used for echocardiography, which involves using ultrasound to produce images of the heart, allowing for their storage and review in a medical setting.

• How is the Echocardiography System Series 95000 supplied?

  The device is supplied by Camtronics, Ltd. and is designed to be used with echocardiography equipment in a medical setting.

• What is the regulatory status of the Echocardiography System Series 95000?

  The device has been cleared under the FDA 510(k) process with the clearance number K992259, classified as Class II with Special Controls.