Dx-D 100
FDA 510(k) K103597 · Agfa Healthcare N.V.
510(k) numberK103597
Submission
- Device name
- Dx-D 100
- Applicant
- Agfa Healthcare N.V.
Greenville, SC, US - Received
- December 8, 2010
- Decision date
- January 3, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Dx-D 100 cleared by the FDA?
Dx-D 100 (K103597) received a 510(k) decision of Substantially Equivalent on January 3, 2011, 26 days after the submission was received.
What is the product code of K103597?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.