Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600
FDA 510(k) K911384 · Endosonics Corp.
510(k) numberK911384
Submission
- Device name
- Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600
- Applicant
- Endosonics Corp.
Rancho Cordova, CA, US - Received
- March 28, 1991
- Decision date
- June 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
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| 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 |
| K904975 | Vista Viewing StationDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
More from Prism Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000820 | Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter, Model 85700DQO · Special | 06/05/2000SE |
| K990271 | Endosonics Trak Back DeviceDQX · Traditional | 08/30/1999SE |
| K982329 | Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900)ITX · Traditional | 01/14/1999SE |
| K965223 | Resolve Option for the Oracle in Vision Intravascular Ultrasonic Imaging SystemIYO · Traditional | 06/29/1998SE |
| K963290 | Colorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging SystemIYO · Traditional | 08/06/1997SE |
| K962293 | Endosonics Automatic Pull Back DeviceITX · Traditional | 09/16/1996SE |
| K950276 | Microsound 6.6F Diagnostic Imaging Catheter Model 50302, Intravascular Ultrasound…IYO · Traditional | 09/22/1995SE |
| K944004 | Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)IYO · Traditional | 05/04/1995SE |
| K926252 | Cathscanner II Intravascular Ultrasonic Imaging SyIYO · Traditional | 10/25/1993SE |
| K924980 | Cathscanner Visions Microrail Ultra Imag CathITX · Traditional | 01/15/1993SE |
Questions and answers
When was Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600 cleared by the FDA?
Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600 (K911384) received a 510(k) decision of Substantially Equivalent on June 25, 1991, 89 days after the submission was received.
What is the product code of K911384?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.