Aloka SSD-1400 Diagnostic Ultrasound System
FDA 510(k) K972465 · Aloka Co., Ltd.
510(k) numberK972465
Submission
- Device name
- Aloka SSD-1400 Diagnostic Ultrasound System
- Applicant
- Aloka Co., Ltd.
Wallingford, CT, US - Received
- July 1, 1997
- Decision date
- August 15, 1997
- 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 |
|---|---|---|
| K111227 | Aloka SSD-3500 Diagnostic Ultrasound SystemIYN · Traditional | 05/13/2011SE |
| K110207 | Aloka Prousound F75 Diagnostic Ultrasound SystemIYN · Traditional | 02/17/2011SE |
| K093488 | Aloka Prosound Alpha 6 Diagnostic Ultrasound SystemIYO · Traditional | 11/20/2009SE |
| K083254 | Aloka Prousound 2 Diagnostic Ultrasound SystemIYN · Traditional | 12/19/2008SE |
| K081843 | Ultrasound Data Analysis System, Model DAS-RS1LLZ · Traditional | 07/15/2008SE |
| K080176 | Aloka Prosound 6 Diagnostic Ultrasound SystemIYN · Traditional | 02/29/2008SE |
| K072285 | Aloka Ssd-Alpha 7 Ultrasound SystemITX · Traditional | 08/30/2007SE |
| K060059 | Aloka SD-3500 Ultrasound SystemIYN · Traditional | 01/13/2006SE |
| K043196 | Aloka Ssd-Alpha 10 Ultrasound SystemIYN · Traditional | 11/30/2004SE |
| K040719 | Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System AccessoryIYO · Traditional | 03/26/2004SE |
Questions and answers
When was Aloka SSD-1400 Diagnostic Ultrasound System cleared by the FDA?
Aloka SSD-1400 Diagnostic Ultrasound System (K972465) received a 510(k) decision of Substantially Equivalent on August 15, 1997, 45 days after the submission was received.
What is the product code of K972465?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.