Ultrasound Scanner Pro Focus 2202
FDA 510(k) K132685 · B-K Medical Aps
510(k) numberK132685
Submission
- Device name
- Ultrasound Scanner Pro Focus 2202
- Applicant
- B-K Medical Aps
Herlev, DK - Received
- August 28, 2013
- Decision date
- January 6, 2014
- 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 |
|---|---|---|
| K140428 | Ultrasound Scanner System BK2300IYO · Abbreviated | 05/30/2014SE |
| K132346 | Ultrasound Scanner Pro Focus 2202IYO · Traditional | 01/10/2014SE |
| K132335 | Ultrasound Scanner Flex Focus 1202IYN · Traditional | 01/10/2014SE |
| K132677 | Ultrasound Scanner Flex Focus 1202IYN · Traditional | 01/07/2014SE |
| K123254 | Ultrasound Scanner Flex FocusIYN · Traditional | 02/13/2013SE |
| K100919 | Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202IYN · Traditional | 12/16/2011SE |
| K083667 | Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model Ua 1336, Needle Guide…ITX · Traditional | 02/02/2009SE |
| K081323 | Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818FCG · Traditional | 07/22/2008SE |
| K081154 | Ultrasound Scanner Flex Focus, Model 1202IYO · Special | 05/23/2008SE |
| K070077 | Ultrasound Scanner Profocus, Model 2202IYO · Traditional | 03/05/2007SE |
Questions and answers
When was Ultrasound Scanner Pro Focus 2202 cleared by the FDA?
Ultrasound Scanner Pro Focus 2202 (K132685) received a 510(k) decision of Substantially Equivalent on January 6, 2014, 131 days after the submission was received.
What is the product code of K132685?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.