NOBLUS Ultrasound Diagnostic System
FDA 510(k) K160559 · Hitachi Medical Corporation
510(k) numberK160559
Submission
- Device name
- NOBLUS Ultrasound Diagnostic System
- Applicant
- Hitachi Medical Corporation
Wallingford, CT, US - Received
- February 29, 2016
- Decision date
- October 18, 2016
- 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
| 510(k) | Device | Decision |
|---|---|---|
| K073310 | Oasis CTL Coil, Od Flexible Body Coil (L and XL), and Rapid Foot CoilMOS · Abbreviated | 01/18/2008SE |
| K061608 | Modification to EUB-5500 Diagnostic Ultrasound ScannerIYN · Special | 11/22/2006SE |
| K053258 | EUB-6500 Diagnostic Ultrasound ScannerIYN · Special | 12/09/2005SE |
| K042501 | ETG-4000 Optical Topography SystemDQA · Special | 10/12/2004SE |
| K013722 | Modification to: EUB-8500 Diagnostic Ultrasound ScannerIYN · Special | 02/11/2002SE |
| K013723 | Modification to: EUB-6500 Diagnostic Ultrasound ScannerITX · Special | 02/06/2002SE |
| K012239 | Modifications to EUB-525 Diagnostic Ultrasound Scanner; EUB-2000 Diagnostic Ultrasound…IYN · Traditional | 08/10/2001SE |
| K011252 | EUB-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe SystemIYO · Traditional | 05/30/2001SE |
| K926209 | EUB-555IYO · Traditional | 06/03/1994SE |
| K910268 | Transducers, EUP-C318/V33/F334/CC331/B31/032TITX · Traditional | 04/15/1991SE |
Questions and answers
When was NOBLUS Ultrasound Diagnostic System cleared by the FDA?
NOBLUS Ultrasound Diagnostic System (K160559) received a 510(k) decision of Substantially Equivalent on October 18, 2016, 232 days after the submission was received.
What is the product code of K160559?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.