FDA product code DXK: Echocardiograph
DXK is the FDA product code for echocardiograph. It is a Class II device, regulated under 21 CFR 870.2330 and reviewed by the Cardiovascular panel. FDA has cleared 78 510(k) submissions under DXK, from 53 different applicants. The average 510(k) review took 115 days (median 94).
Classification
| Field | Value |
|---|---|
| Device name | Echocardiograph |
| Device class | Class II |
| Regulation | 21 CFR 870.2330 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 28 |
Compare with all 510(k) review times · Search every DXK clearance
Top DXK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biosound, Inc. | 5 | 1992-05-15 |
| Hewlett-Packard Co. | 4 | 1991-04-22 |
| Prism Imaging, Inc. | 4 | 1991-02-25 |
| Hitachi Medical Corp. of America | 4 | 1990-09-04 |
| Advanced Technology Laboratories, Inc. | 3 | 1990-02-15 |
48 more applicants have DXK clearances. See the full list in Caduvo.
Most recent DXK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181042 | Boston Scientific Corporation | Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter | 2018-05-17 | 28 |
| K160173 | Boston Scientific Corporation | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) | 2016-02-26 | 30 |
| K031148 | Jomed, Inc. | IN-VISION IMAGING SYSTEM | 2003-05-28 | 48 |
| K934887 | S & W Medico Teknik A/S | 9750 ATHENA ETHERNET OPTION | 1994-01-14 | 94 |
| K913209 | Biosound, Inc. | ACCESSORY TO GENESIS III (GCFM) | 1992-05-15 | 301 |
Recalls for DXK devices
openFDA lists no recalls for product code DXK.
Frequently asked questions
What is FDA product code DXK?
DXK is the FDA product code for echocardiograph. It is a Class II device, regulated under 21 CFR 870.2330 and reviewed by the Cardiovascular panel.
What device class is DXK?
Class II, regulation 21 CFR 870.2330. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXK?
Across 78 cleared submissions the average was 115 days from receipt to decision (median 94).
Which companies have the most DXK clearances?
Biosound, Inc. (5); Hewlett-Packard Co. (4); Prism Imaging, Inc. (4); Hitachi Medical Corp. of America (4); Advanced Technology Laboratories, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code DXK
- Run a recall and safety report across every DXK manufacturer
- Watch product code DXK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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