CR Mammography System with Dx-M Digitizer
FDA 510(k) K111324 · Agfa Healthcare N.V.
510(k) numberK111324
Submission
- Device name
- CR Mammography System with Dx-M Digitizer
- Applicant
- Agfa Healthcare N.V.
Greenville, SC, US - Received
- May 11, 2011
- Decision date
- December 22, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was CR Mammography System with Dx-M Digitizer cleared by the FDA?
CR Mammography System with Dx-M Digitizer (K111324) received a 510(k) decision of Substantially Equivalent on December 22, 2011, 225 days after the submission was received.
What is the product code of K111324?
The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.