Color Doppler 880
FDA 510(k) K843643 · Irex Corp.
510(k) numberK843643
Submission
- Device name
- Color Doppler 880
- Applicant
- Irex Corp.
Ramsey, NJ, US - Received
- September 17, 1984
- Decision date
- January 31, 1985
- 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 |
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| K904978 | Software Program Used W/Prism ProductsDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
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| K904976 | Cine'View - Stress Echo & Image ReviewDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
More from Prism Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K844404 | Irex PS, Portable Scanner and 118IYO · Traditional | 02/04/1985SE |
| K842408 | Irex 730 Mechanical Sector ScannerJAF · Traditional | 11/29/1984SE |
| K840139 | Irex 720 Sector ScannerIYO · Traditional | 05/09/1984SE |
| K827370 | Irex System II 2D/DOPPLER Imaging System · Traditional | 06/28/1982SE |
| K813544 | Irex 2D/DOPPLER Phase Array Imaging Sys.IYN · Traditional | 02/05/1982SE |
| K811246 | Doppler Ultrasound Blood FlowmeterDPW · Traditional | 08/12/1981SE |
| K792525 | Irex CardioplanDQK · Traditional | 12/27/1979SE |
| K791317 | Irex Real Time Phased Array SystemCDP · Traditional | 09/17/1979SE |
| K771372 | System IIDSF · Traditional | 08/04/1977SE |
Questions and answers
When was Color Doppler 880 cleared by the FDA?
Color Doppler 880 (K843643) received a 510(k) decision of Substantially Equivalent on January 31, 1985, 136 days after the submission was received.
What is the product code of K843643?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.