Aspire Cristalle
FDA 510(k) K133972 · Fujifilm Medical Systems U.S.A, Inc.
510(k) numberK133972
Submission
- Device name
- Aspire Cristalle
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
Stamford, CT, US - Received
- December 26, 2013
- Decision date
- March 25, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Aspire Cristalle cleared by the FDA?
Aspire Cristalle (K133972) received a 510(k) decision of Substantially Equivalent on March 25, 2014, 89 days after the submission was received.
What is the product code of K133972?
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.