Enterprise Imaging XERO Viewer 8.1
FDA 510(k) K170434 · Agfa Healthcare N.V.
510(k) numberK170434
Submission
- Device name
- Enterprise Imaging XERO Viewer 8.1
- Applicant
- Agfa Healthcare N.V.
Mortsel, BE - Received
- February 13, 2017
- Decision date
- July 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Enterprise Imaging XERO Viewer 8.1 cleared by the FDA?
Enterprise Imaging XERO Viewer 8.1 (K170434) received a 510(k) decision of Substantially Equivalent on July 3, 2017, 140 days after the submission was received.
What is the product code of K170434?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.