ADX6000 Portable X-Ray System; iRayA6
FDA 510(k) K143494 · Dexcowin Co., Ltd.
510(k) numberK143494
Submission
- Device name
- ADX6000 Portable X-Ray System; iRayA6
- Applicant
- Dexcowin Co., Ltd.
Seoul, KR - Received
- December 9, 2014
- Decision date
- October 5, 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 ADX6000 Portable X-Ray System; iRayA6 cleared by the FDA?
ADX6000 Portable X-Ray System; iRayA6 (K143494) received a 510(k) decision of Substantially Equivalent on October 5, 2015, 300 days after the submission was received.
What is the product code of K143494?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.