Sonoace 9900 Diagnostic Ultrasound System
FDA 510(k) K012867 · Medison America, Inc.
510(k) numberK012867
Submission
- Device name
- Sonoace 9900 Diagnostic Ultrasound System
- Applicant
- Medison America, Inc.
San Leandro, CA, US - Received
- August 27, 2001
- Decision date
- September 12, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K032329 | SA 9900 Plus Diagnostic Ultrasound SystemIYN · Traditional | 08/06/2003SE |
| K031552 | Mycolor 202 Diagnostic Ultrasound System and TransducersIYN · Traditional | 05/30/2003SE |
| K013627 | Sonoace SA-8000 Diagnostic Ultrasound SystemIYN · Traditional | 11/16/2001SE |
| K012887 | SA6000II Diagnostic Ultrasound SystemIYO · Traditional | 09/12/2001SE |
| K003525 | Voluson 730 Diagnostic Ultrasound SystemIYN · Traditional | 11/22/2000SE |
| K003121 | Mysono 201 Diagnostic Ultrasound and TransducersIYO · Traditional | 10/20/2000SE |
| K002185 | Sonoace SA 9900 Diagnostic Ultrasound SystemIYN · Traditional | 08/01/2000SE |
| K000030 | Sonoace 600 Diagnostic Ultrasound SystemIYO · Traditional | 01/19/2000SE |
| K993517 | Combison 530D/VOLUSON 530D, Tissue Harmonic Imaging (Thi) OptionIYO · Traditional | 11/02/1999SE |
| K992761 | Sonoace 5500 Diagnostic Ultrasound SystemIYO · Traditional | 09/01/1999SE |
Questions and answers
When was Sonoace 9900 Diagnostic Ultrasound System cleared by the FDA?
Sonoace 9900 Diagnostic Ultrasound System (K012867) received a 510(k) decision of Substantially Equivalent on September 12, 2001, 16 days after the submission was received.
What is the product code of K012867?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.