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Echo-Com For MS-Windows Version 2.0

by Cone Instruments, Inc.

510(k) K960665

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960665 Date7 May 1996ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Echo-Com For MS-Windows Version 2.0 is a cardiac software program designed for quantitative analysis of M-mode, B-mode, and Doppler ultrasound data. It is classified as a Class II X-ray system manufactured by Cone Instruments, Inc. The device is intended for use in radiology departments for processing and analyzing ultrasound cardiac data.

The device is supplied as software for MS-Windows and is not specified as single-use or reusable. It received FDA 510(k) clearance with K-number K960665 on May 7, 1996, after a 77-day review. The clearance was granted under the Traditional pathway with product code LLZ and reviewed by the Radiology advisory committee.

Other devices from Cone Instruments, Inc.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Echo-Com For MS-Windows Version 2.0 used for?

    Echo-Com For MS-Windows Version 2.0 is a cardiac software program designed for quantitative analysis of M-mode, B-mode, and Doppler ultrasound data. It is intended for use in radiology departments for processing and analyzing ultrasound cardiac data.

  • How is Echo-Com For MS-Windows Version 2.0 supplied?

    The device is supplied as software for MS-Windows. It is not specified as single-use or reusable in the provided information.

  • What regulatory approvals does Echo-Com For MS-Windows Version 2.0 have?

    Echo-Com For MS-Windows Version 2.0 received FDA 510(k) clearance with K-number K960665 on May 7, 1996, after a 77-day review. The clearance was granted under the Traditional pathway with product code LLZ and reviewed by the Radiology advisory committee.

  • What classification is Echo-Com For MS-Windows Version 2.0?

    The device is classified as a Class II X-ray system manufactured by Cone Instruments, Inc. It is intended for use in radiology departments for processing and analyzing ultrasound cardiac data.