Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-10-27 under 510(k) 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. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K173132.

When did ASPIRE Cristalle receive FDA 510(k) clearance?

ASPIRE Cristalle received FDA 510(k) clearance on 2017-10-27, under 510(k) number K173132.

Who is the listed applicant for ASPIRE Cristalle?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASPIRE Cristalle?

The FDA product code for ASPIRE Cristalle is MUE.

Other records listing Fujifilm Medical Systems U.S.A, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P160031Digital breast tomosynthesisK171291FUJIFILM Bronchoscope Model EB-530PK171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MK171463ASPIRE Bellus IIK152257Fujifilm Duodenoscope Model ED-530XTK163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)

View all 17 devices →

Related Devices (Code: MUE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.K254092Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd.K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCSK243420HESTIAGenoray Co., Ltd.K2438492430TCA with Xmaru WRayence Co., Ltd.K241113VIVIX-MVieworks Co., Ltd.

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.

↑