DR 600 with Tomosynthesis
FDA 510(k) K193262 · Agfa N.V.
510(k) numberK193262
Submission
- Device name
- DR 600 with Tomosynthesis
- Applicant
- Agfa N.V.
Mortsel, BE - Received
- November 26, 2019
- Decision date
- March 9, 2020
- 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 600 with Tomosynthesis cleared by the FDA?
DR 600 with Tomosynthesis (K193262) received a 510(k) decision of Substantially Equivalent on March 9, 2020, 104 days after the submission was received.
What is the product code of K193262?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.