DR 100s
FDA 510(k) K191884 · Agfa N.V.
510(k) numberK191884
Submission
- Device name
- DR 100s
- Applicant
- Agfa N.V.
Mortsel, BE - Received
- July 15, 2019
- Decision date
- August 9, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was DR 100s cleared by the FDA?
DR 100s (K191884) received a 510(k) decision of Substantially Equivalent on August 9, 2019, 25 days after the submission was received.
What is the product code of K191884?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.