Xario 200 Diagnostic Ultrasound System V6.0
FDA 510(k) K172276 · Toshibamedical Systems Corporation
510(k) numberK172276
Submission
- Device name
- Xario 200 Diagnostic Ultrasound System V6.0
- Applicant
- Toshibamedical Systems Corporation
Otawara-Shi, JP - Received
- July 28, 2017
- Decision date
- December 12, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| K173468 | Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0JAK · Traditional | 02/23/2018SE |
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| K173382 | Vantage Galan 3T, V4.6LNH · Traditional | 01/26/2018SE |
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| K172863 | Infinix-i, INFX-8000V, V7.0OWB · Traditional | 12/14/2017SE |
| K172646 | XIDF-AWS801, Angio Workstation, V7.0OWB · Traditional | 10/30/2017SE |
| K171597 | Vantage Elan 1.5T, V4.0LNH · Traditional | 07/21/2017SE |
| K170832 | Ultimax-i, DREX-UI80 V1.60OWB · Traditional | 07/21/2017SE |
| K170177 | Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1JAK · Traditional | 06/30/2017SE |
Questions and answers
When was Xario 200 Diagnostic Ultrasound System V6.0 cleared by the FDA?
Xario 200 Diagnostic Ultrasound System V6.0 (K172276) received a 510(k) decision of Substantially Equivalent on December 12, 2017, 137 days after the submission was received.
What is the product code of K172276?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.