EPX-Series Mobile X-ray System
FDA 510(k) K151038 · Ecotron Co., Ltd.
510(k) numberK151038
Submission
- Device name
- EPX-Series Mobile X-ray System
- Applicant
- Ecotron Co., Ltd.
Seoul, KR - Received
- April 20, 2015
- Decision date
- July 24, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was EPX-Series Mobile X-ray System cleared by the FDA?
EPX-Series Mobile X-ray System (K151038) received a 510(k) decision of Substantially Equivalent on July 24, 2015, 95 days after the submission was received.
What is the product code of K151038?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.