Sinvision Linear Array Real Time
FDA 510(k) K800653 · Kt Medical, Inc.
510(k) numberK800653
Submission
- Device name
- Sinvision Linear Array Real Time
- Applicant
- Kt Medical, Inc.
Mchenry, IL, US - Received
- March 24, 1980
- Decision date
- July 21, 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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| 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 |
|---|---|---|
| K800652 | Model E03 Echo-OpthalmoscopeIYO · Traditional | 05/14/1980SE |
| K800101 | 4200 Me EchoencephalographIYO · Traditional | 05/02/1980SE |
| K800092 | Combison ComputerDQK · Traditional | 04/08/1980SE |
| K800100 | 7200 Ma Echo-OphthalmoscopeIYO · Traditional | 02/21/1980SE |
| K800099 | Intracula IIIYO · Traditional | 02/21/1980SE |
| K800098 | Minifeton 200KNG · Traditional | 02/11/1980SE |
| K800097 | Minivason 9JAF · Traditional | 02/11/1980SE |
| K800096 | Ambivason DR-200JAF · Traditional | 02/11/1980SE |
| K800095 | MGD-3KNG · Traditional | 02/11/1980SE |
| K800094 | Combison 200 & Combison 202IYO · Traditional | 02/11/1980SE |
Questions and answers
When was Sinvision Linear Array Real Time cleared by the FDA?
Sinvision Linear Array Real Time (K800653) received a 510(k) decision of Substantially Equivalent on July 21, 1980, 119 days after the submission was received.
What is the product code of K800653?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.