Cathscanner(R) Intravascular Ultra Imaging System
FDA 510(k) K893042 · Endosonics Corp.
510(k) numberK893042
Submission
- Device name
- Cathscanner(R) Intravascular Ultra Imaging System
- Applicant
- Endosonics Corp.
Rancho Cordova, CA, US - Received
- April 24, 1989
- Decision date
- July 19, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IYN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261313 | Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 09/02/2026SE |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional | Sonoscape Medical Corp. | 08/24/2026SE |
| K261668 | Venue GoIYN · Traditional | GE Medical Systems Ultrasound and Primary care… | 08/07/2026SE |
| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 08/04/2026SE |
| K261835 | LOGIQ FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/30/2026SE |
| K261288 | Handheld Ultrasound ScannerIYN · Traditional | Imgfax Co., Ltd. | 07/30/2026SE |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional | Samsung Medison Co., Ltd. | 07/28/2026SE |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | Philips Ultrasound, LLC | 07/27/2026SE |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 07/23/2026SE |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
More from Beijing Konted Medical Technology Co.,Ltd
| 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) Intravascular Ultra Imaging System cleared by the FDA?
Cathscanner(R) Intravascular Ultra Imaging System (K893042) received a 510(k) decision of Substantially Equivalent on July 19, 1989, 86 days after the submission was received.
What is the product code of K893042?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.