Cleared Traditional

Aspire Cristalle

K212873 · Fujifilm Corporation · Radiology
May 2022
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K212873 is an FDA 510(k) clearance for the Aspire Cristalle, a Full Field Digital, System, X-ray, Mammographic (Class II — Special Controls, product code MUE), submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on May 27, 2022, 260 days after receiving the submission on September 9, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number K212873 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2021
Decision Date May 27, 2022
Days to Decision 260 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUE — Full Field Digital, System, X-ray, Mammographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1715