Sonacolor 6000
FDA 510(k) K792540 · Carolina Medical Electronics
510(k) numberK792540
Submission
- Device name
- Sonacolor 6000
- Applicant
- Carolina Medical Electronics
Mchenry, IL, US - Received
- December 10, 1979
- Decision date
- January 17, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXK – Echocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2330
- Specialty
- Cardiovascular
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|---|---|---|---|
| K181042 | Ultra ICE Plus PI 9 MHz Peripheral Imaging CatheterDXK · Special | Boston Scientific Corporation | 05/17/2018SE |
| K160173 | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac…DXK · Special | Boston Scientific Corporation | 02/26/2016SE |
| K031148 | In-Vision Imaging SystemDXK · Special | Jomed, Inc. | 05/28/2003SE |
| K934887 | 9750 Athena Ethernet OptionDXK · Traditional | S & W Medico Teknik A/S | 01/14/1994SE |
| K913209 | Accessory to Genesis III (GCFM)DXK · Traditional | Biosound, Inc. | 05/15/1992SE |
| K911384 | Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600DXK · Traditional | Endosonics Corp. | 06/25/1991SE |
| K904832 | Modified Syst: Sonos 500/1000 Ultrsound Imag SystDXK · Traditional | Hewlett-Packard Co. | 04/22/1991SE |
| K904978 | Software Program Used W/Prism ProductsDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904977 | Cine/View Plus - Cardiology WorkstationDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904976 | Cine'View - Stress Echo & Image ReviewDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
More from Prism Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K914200 | Vascumap Medical Air PlethysmographDSB · Traditional | 11/07/1991SE |
| K874685 | Trans-Scan 3-D Transcranial DopplerIYO · Traditional | 04/25/1988SE |
| K874684 | TC2-64B Transcranial DopplerIYO · Traditional | 04/25/1988SE |
| K864624 | Probe, Uptake, NuclearIZO · Traditional | 08/10/1987SE |
| K843891 | Dopscan Plus DS1060IYO · Traditional | 01/09/1985SE |
| K837329 | Sonacolor CD, Model 6300 Cardiac Doppler Ultrasound · Traditional | 06/07/1983SE |
| K820272 | Cliniflow II, #701, Electromagn. Bld. SyDPW · Traditional | 03/12/1982SE |
| K810561 | Dopscan Model 1050DPW · Traditional | 04/10/1981SE |
| K801647 | Sonacolor 6100DXY · Traditional | 08/20/1980SE |
| K772015 | Patient Heater System, Model PH112DWJ · Traditional | 11/15/1977SE |
Questions and answers
When was Sonacolor 6000 cleared by the FDA?
Sonacolor 6000 (K792540) received a 510(k) decision of Substantially Equivalent on January 17, 1980, 38 days after the submission was received.
What is the product code of K792540?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.