Diagnostic Ultrasound System
FDA 510(k) K132059 · Advanced Instrumentations, Inc.
510(k) numberK132059
Submission
- Device name
- Diagnostic Ultrasound System
- Applicant
- Advanced Instrumentations, Inc.
Hialeah, FL, US - Received
- July 3, 2013
- Decision date
- October 25, 2013
- 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 |
|---|---|---|
| K172931 | DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemIYO · Abbreviated | 12/01/2017SE |
| K172055 | DUS-7000 Digital Color Doppler Ultrasound SystemIYN · Abbreviated | 08/31/2017SE |
| K141194 | FM-3000 Fetal MonitorHGM · Traditional | 11/19/2014SE |
| K132077 | Patient MonitorMHX · Traditional | 04/23/2014SE |
| K123048 | Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProMHX · Traditional | 01/11/2013SE |
| K120075 | AM-6000 Anesthesia MachineBSZ · Traditional | 01/26/2012SE |
| K112317 | FM-9000 Plus Fetal and Maternal MonitorHGM · Traditional | 12/21/2011SE |
| K112529 | TD-5000 & TD-6000 Ultrasonic Tabletop DopplerKNG · Traditional | 10/27/2011SE |
| K112022 | DUS-3000/DUS-3000PLUS Digital Ultrasonic Diagnostic Imaging SystemIYO · Traditional | 09/22/2011SE |
| K111934 | PD-100 Series Ultrasonic Pocket DopplerKNG · Traditional | 09/22/2011SE |
Questions and answers
When was Diagnostic Ultrasound System cleared by the FDA?
Diagnostic Ultrasound System (K132059) received a 510(k) decision of Substantially Equivalent on October 25, 2013, 114 days after the submission was received.
What is the product code of K132059?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.