E-Cube 15
FDA 510(k) K121888 · Alpinion Medical Systems Co., Ltd.
510(k) numberK121888
Submission
- Device name
- E-Cube 15
- Applicant
- Alpinion Medical Systems Co., Ltd.
Seoul, KR - Received
- June 28, 2012
- Decision date
- July 26, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K223564 | X-Cube 50, X-Cube 60IYN · Traditional | 04/17/2023SE |
| K221093 | X-Cube 70, X-Cube 90IYN · Traditional | 10/14/2022SE |
| K220857 | X-Cube 50, X-Cube 60IYN · Traditional | 10/13/2022SE |
| K213523 | X-CUBE i8, X-CUBE i9IYN · Traditional | 01/28/2022SE |
| K211300 | X-Cube 90IYN · Traditional | 08/09/2021SE |
| K211299 | X-Cube 70IYN · Traditional | 08/09/2021SE |
| K200450 | X-Cube 70IYN · Traditional | 07/10/2020SE |
| K200449 | X-Cube 90IYN · Traditional | 07/10/2020SE |
| K182594 | E-CUBE i7IYN · Traditional | 01/24/2019SE |
| K182845 | minisonoIYN · Traditional | 12/27/2018SE |
Questions and answers
When was E-Cube 15 cleared by the FDA?
E-Cube 15 (K121888) received a 510(k) decision of Substantially Equivalent on July 26, 2012, 28 days after the submission was received.
What is the product code of K121888?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.