Colormark(Tm) Visualization System
FDA 510(k) K926351 · Echocath, Inc.
510(k) numberK926351
Submission
- Device name
- Colormark(Tm) Visualization System
- Applicant
- Echocath, Inc.
Princeton, NJ, US - Received
- December 17, 1992
- Decision date
- September 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYN
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|---|---|---|---|
| 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
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| K010482 | Echoflow Portable Doppler Blood Flow Measurement System; Model PEF-1JOP · Special | 03/20/2001SE |
| K990642 | Echoflow Doppler Blood Velocity MeterJOP · Traditional | 09/16/1999SE |
| K932436 | Echomark Intrauterine Guiding CatheterMOV · Traditional | 11/16/1995SE |
| K933417 | Echomark(R) Electrophysiology CatheterDRF · Traditional | 05/04/1995SE |
| K922787 | Echomark Guidewire with Ultrasonic LocalizationDQX · Traditional | 01/06/1993SE |
Questions and answers
When was Colormark(Tm) Visualization System cleared by the FDA?
Colormark(Tm) Visualization System (K926351) received a 510(k) decision of Substantially Equivalent on September 16, 1993, 273 days after the submission was received.
What is the product code of K926351?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.