ASPIRE Bellus II
K-Number: K171463 · 2017-09-29
ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2017-09-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ASPIRE Bellus II is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-09-29 under approval number K171463. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ASPIRE Bellus II?
ASPIRE Bellus II is a medical device that received FDA 510(k) clearance on 2017-09-29. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K171463.
When was ASPIRE Bellus II approved by the FDA?
ASPIRE Bellus II received FDA 510(k) clearance on 2017-09-29, under approval number K171463.
What company makes ASPIRE Bellus II?
ASPIRE Bellus II is manufactured by Fujifilm Medical Systems U.S.A, Inc..
What is the FDA product code for ASPIRE Bellus II?
The FDA product code for ASPIRE Bellus II is LLZ.
Other Devices by Fujifilm Medical Systems U.S.A, Inc.
Related Devices (Code: LLZ)
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.