Cine'View - Stress Echo & Image Review
FDA 510(k) K904976 · Prism Imaging, Inc.
510(k) numberK904976
Submission
- Device name
- Cine'View - Stress Echo & Image Review
- Applicant
- Prism Imaging, Inc.
Washington, DC, US - Received
- November 1, 1990
- Decision date
- February 25, 1991
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K904975 | Vista Viewing StationDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
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Questions and answers
When was Cine'View - Stress Echo & Image Review cleared by the FDA?
Cine'View - Stress Echo & Image Review (K904976) received a 510(k) decision of Substantially Equivalent on February 25, 1991, 116 days after the submission was received.
What is the product code of K904976?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.