Prosound F37 Diagnostic Ultrasound System, Model: Prosound F37
FDA 510(k) K122341 · Hitachi Aloka Medical, Ltd.
510(k) numberK122341
Submission
- Device name
- Prosound F37 Diagnostic Ultrasound System, Model: Prosound F37
- Applicant
- Hitachi Aloka Medical, Ltd.
Wallingford, CT, US - Received
- August 2, 2012
- Decision date
- September 26, 2012
- 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 |
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| K142368 | Noblus Diagnostic Ultrasound ScannerIYN · Traditional | 01/14/2015SE |
| K140854 | Intra-Operative Ultrasound TransducerITX · Traditional | 06/11/2014SE |
| K140639 | Prosound F75 Diagnostic Ultrasound SystemIYN · Traditional | 04/16/2014SE |
| K130308 | Noblus Ultrasound Diagnostic SystemIYN · Special | 04/05/2013SE |
| K123828 | Prosound F75 Diagnostic Ultrasound SystemIYN · Traditional | 01/18/2013SE |
Questions and answers
When was Prosound F37 Diagnostic Ultrasound System, Model: Prosound F37 cleared by the FDA?
Prosound F37 Diagnostic Ultrasound System, Model: Prosound F37 (K122341) received a 510(k) decision of Substantially Equivalent on September 26, 2012, 55 days after the submission was received.
What is the product code of K122341?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.