DXKClass II

Echocardiograph

21 CFR 870.2330 / Cardiovascular

DXK is the FDA product code for Echocardiograph, a class II device type, regulated under 21 CFR 870.2330. As of 2026-09-10, FDA records hold 78 510(k) clearances under this code, the most recent dated 2018-05-17, and no recalls.

Classification record

Product code: DXK
Device name: Echocardiograph
Regulation: 21 CFR 870.2330
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 78
Ingested recalls: 0

Clearances, product code DXK

By decision year

78 clearances under product code DXK with a decision year between 1977 and 2018, 1990 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code DXK by decision year
Year	Clearances
1977	4
1978	1
1980	10
1981	6
1982	4
1984	1
1985	6
1986	6
1987	6
1988	7
1989	3
1990	12
1991	7
1992	1
1994	1
2003	1
2016	1
2018	1

Applicants with the most clearances

Product code DXK

Applicants holding the most 510(k) clearances under product code DXK
Applicant	Clearances
Biosound, Inc.	5
Hewlett-Packard Co.	4
Hitachi Medical Corp. of America	4
Prism Imaging, Inc.	4
Advanced Technology Laboratories, Inc.	3
Honeywell, Inc.	3
Philips North America LLC	3
Toshiba Medical Systems	3
Boston Scientific Corporation	2
Del Mar Avionics	2

Companies listing this code with FDA

Companies whose registered establishments list this code