DC-1 Cardiac Imaging Module
FDA 510(k) K811556 · Diasonics, Inc.
510(k) numberK811556
Submission
- Device name
- DC-1 Cardiac Imaging Module
- Applicant
- Diasonics, Inc.
Mchenry, IL, US - Received
- June 2, 1981
- Decision date
- July 10, 1981
- 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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| 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.
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|---|---|---|
| K962662 | Vingmed Sound Color Flow Mapping SystemIYO · Traditional | 01/02/1997SE |
| K924079 | CFM-800 Color Flow Mapping SystemIYO · Traditional | 09/28/1993SE |
| K911435 | CPA/3.5 MHZ ProbeITX · Traditional | 09/11/1992SE |
| K905200 | Saca, 3.5 MHZ ProbeITX · Traditional | 04/02/1992SE |
| K903562 | CW Doppler 2.25 MHZ ProbeITX · Traditional | 03/02/1992SE |
| K903984 | CW DOPPLER/4.5 MHZITX · Traditional | 06/14/1991SE |
| K896637 | Access(Tm), Software Release 4.11PLPH · Traditional | 01/22/1990SE |
| K893518 | Mt/S Software Release 5.0.LNH · Traditional | 10/27/1989SE |
| K894290 | Access TMLNH · Traditional | 09/07/1989SE |
| K893881 | Access TMLNH · Traditional | 06/23/1989SE |
Questions and answers
When was DC-1 Cardiac Imaging Module cleared by the FDA?
DC-1 Cardiac Imaging Module (K811556) received a 510(k) decision of Substantially Equivalent on July 10, 1981, 38 days after the submission was received.
What is the product code of K811556?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.