Neuroguard Transcranial Doppler Ultrasound System
FDA 510(k) K962796 · Medasonics, Inc.
510(k) numberK962796
Submission
- Device name
- Neuroguard Transcranial Doppler Ultrasound System
- Applicant
- Medasonics, Inc.
Sandy, UT, US - Received
- July 18, 1996
- Decision date
- January 21, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K991441 | Cadence Doppler Ultrasound SystemKNG · Traditional | 12/28/1999SE |
| K961116 | First Beat/Cardio Beat/CalcIYO · Traditional | 08/08/1996SE |
| K914862 | Cerebrovascular Diagnostic System; CDSIYN · Traditional | 12/03/1992SE |
| K911453 | Obtrasound Stethoscope Fetal CalcKNG · Traditional | 06/20/1991SE |
| K882018 | Medacord PVL, Personal Vascular LaboratoryJAF · Traditional | 09/21/1988SE |
| K872292 | Transpect Transcranial DopplerIYN · Traditional | 08/14/1987SE |
| K854734 | Model 5320 Ted Sequential Comp. De. Comp. Limb SleDRM · Traditional | 02/10/1986SE |
| K833588 | Vascular Laboratory Treadmill VT1IOL · Traditional | 11/14/1983SE |
| K837481 | BF24 Doppler Model P872 and P874 · Traditional | 06/24/1983SE |
| K831393 | Vasculab Blood Pressure CuffDXQ · Traditional | 06/16/1983SE |
Questions and answers
When was Neuroguard Transcranial Doppler Ultrasound System cleared by the FDA?
Neuroguard Transcranial Doppler Ultrasound System (K962796) received a 510(k) decision of Substantially Equivalent on January 21, 1997, 187 days after the submission was received.
What is the product code of K962796?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.