Aspire Cristalle
FDA 510(k) K212873 · Fujifilm Corporation
510(k) numberK212873
Submission
- Device name
- Aspire Cristalle
- Applicant
- Fujifilm Corporation
Ashigara Kami-Gun, JP - Received
- September 9, 2021
- Decision date
- May 27, 2022
- 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 (K212873) received a 510(k) decision of Substantially Equivalent on May 27, 2022, 260 days after the submission was received.
What is the product code of K212873?
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.