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FDA 510(k), K162474, Artemis
FDA 510(k), K162474, Artemis
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510(K) Number: K162474
Device Name: Artemis
Manufacturer: EIGEN
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 09/06/2016
Decision Date: 10/21/2016
Regulation Medical Specialty: Radiology
Device Name: Artemis
Manufacturer: EIGEN
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 09/06/2016
Decision Date: 10/21/2016
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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