Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2330](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2330) → DXK — Echocardiograph # DXK · Echocardiograph _Cardiovascular · 21 CFR 870.2330 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK ## Overview - **Product Code:** DXK - **Device Name:** Echocardiograph - **Regulation:** [21 CFR 870.2330](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2330) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 78) Showing 20 most recent of 78 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K181042](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K181042.md) | Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | May 17, 2018 | SESE | | [K160173](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K160173.md) | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) | Boston Scientific Corporation | Feb 26, 2016 | SESE | | [K031148](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K031148.md) | IN-VISION IMAGING SYSTEM | Jomed, Inc. | May 28, 2003 | SESE | | [K934887](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K934887.md) | 9750 ATHENA ETHERNET OPTION | S & W Medico Teknik A/S | Jan 14, 1994 | SESE | | [K913209](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K913209.md) | ACCESSORY TO GENESIS III (GCFM) | Biosound, Inc. | May 15, 1992 | SESE | | [K911384](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K911384.md) | CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 | Endosonics Corp. | Jun 25, 1991 | SESE | | [K904832](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K904832.md) | MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST | Hewlett-Packard Co. | Apr 22, 1991 | SESE | | [K904978](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K904978.md) | SOFTWARE PROGRAM USED W/PRISM PRODUCTS | Prism Imaging, Inc. | Feb 25, 1991 | SESE | | [K904977](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K904977.md) | CINE/VIEW PLUS - CARDIOLOGY WORKSTATION | Prism Imaging, Inc. | Feb 25, 1991 | SESE | | [K904976](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K904976.md) | CINE'VIEW - STRESS ECHO & IMAGE REVIEW | Prism Imaging, Inc. | Feb 25, 1991 | SESE | | [K904975](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K904975.md) | VISTA VIEWING STATION | Prism Imaging, Inc. | Feb 25, 1991 | SESE | | [K910029](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K910029.md) | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION | Spacelabs, Inc. | Jan 31, 1991 | SESE | | [K903839](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K903839.md) | INTERSPEC APOGEE | Interspec, Inc. | Nov 16, 1990 | SESE | | [K903710](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K903710.md) | WASHINGTON CARDIAC MONITOR | Washington Biolab, Inc. | Nov 9, 1990 | SESE | | [K901592](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K901592.md) | MODEL MD-5 DOPPLER | D. E. Hokanson, Inc. | Oct 22, 1990 | SESE | | [K903414](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K903414.md) | TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN | Echo Ultrasound | Sep 19, 1990 | SESE | | [K901658](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K901658.md) | ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND | Hitachi Medical Corp. of America | Sep 4, 1990 | SESE | | [K901657](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K901657.md) | ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND | Hitachi Medical Corp. of America | Sep 4, 1990 | SESE | | [K900350](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K900350.md) | LEOCOR CORFLO(TM) PUMP | Leocor, Inc. | Jul 17, 1990 | SESE | | [K901562](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K901562.md) | CVIS INSIGHT IMAGING CATHETER | Cardiovascular Imaging Systems, Inc. | Jul 9, 1990 | SESE | ## Top Applicants - Biosound, Inc. — 5 clearances - Hewlett-Packard Co. — 4 clearances - Hitachi Medical Corp. of America — 4 clearances - Prism Imaging, Inc. — 4 clearances - Advanced Technology Laboratories, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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