Cambridge Cardiac Diagnostic System
FDA 510(k) K801224 · Cambridge Instruments, Inc.
510(k) numberK801224
Submission
- Device name
- Cambridge Cardiac Diagnostic System
- Applicant
- Cambridge Instruments, Inc.
Mchenry, IL, US - Received
- May 22, 1980
- Decision date
- June 26, 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
Other 510(k)s with product code DXK
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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 |
|---|---|---|
| K811121 | Central Station Monitoring SystemsDPS · Traditional | 06/30/1981SE |
| K811062 | Campbridge ComputraceDXG · Traditional | 05/29/1981SE |
| K803229 | 4-CHANNEL ECG Telemetry Mon. Syst. #3045DRG · Traditional | 01/13/1981SE |
| K800566 | Cambridge VS-550 ElectrocardiographDPS · Traditional | 04/08/1980SE |
| K792661 | Treadmill Model 3060IOL · Traditional | 02/19/1980SE |
| K791201 | Scintistress SystemDPS · Traditional | 09/17/1979SE |
| K790509 | Cardiocassette II, Ambulatory ECG SystemDSH · Traditional | 03/23/1979SE |
| K761318 | 3038 Option B-Comput. Trans. TerminalDXH · Traditional | 01/06/1977SE |
| K761198 | Model 3044 3-CHANNEL Stress Test SystemDPS · Traditional | 12/09/1976SE |
| K760926 | Electrocardiograph (Model VS-4B)DPS · Traditional | 11/09/1976SE |
Questions and answers
When was Cambridge Cardiac Diagnostic System cleared by the FDA?
Cambridge Cardiac Diagnostic System (K801224) received a 510(k) decision of Substantially Equivalent on June 26, 1980, 35 days after the submission was received.
What is the product code of K801224?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.