Drystar Axys, Model EYZ4E
FDA 510(k) K072680 · Agfa Healthcare Corporation
510(k) numberK072680
Submission
- Device name
- Drystar Axys, Model EYZ4E
- Applicant
- Agfa Healthcare Corporation
Greenville, SC, US - Received
- September 24, 2007
- Decision date
- October 25, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Drystar Axys, Model EYZ4E cleared by the FDA?
Drystar Axys, Model EYZ4E (K072680) received a 510(k) decision of Substantially Equivalent on October 25, 2007, 31 days after the submission was received.
What is the product code of K072680?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.