ASPIRE Cristalle
K-Number: K173132 · 2017-10-27
ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2017-10-27
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ASPIRE Cristalle is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-10-27 under approval number K173132. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ASPIRE Cristalle?
ASPIRE Cristalle is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K173132.
When was ASPIRE Cristalle approved by the FDA?
ASPIRE Cristalle received FDA 510(k) clearance on 2017-10-27, under approval number K173132.
What company makes ASPIRE Cristalle?
ASPIRE Cristalle is manufactured by Fujifilm Medical Systems U.S.A, Inc..
What is the FDA product code for ASPIRE Cristalle?
The FDA product code for ASPIRE Cristalle is MUE.
Other Devices by Fujifilm Medical Systems U.S.A, Inc.
Related Devices (Code: MUE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.