ASPIRE Cristalle— 510(k) K173132
Substantially EquivalentFujifilm Medical Systems U.S.A, Inc.
FDA 510(k) clearance K173132 for ASPIRE Cristalle, Substantially Equivalent on 2017-10-27. Applicant: Fujifilm Medical Systems U.S.A, Inc.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Product code
- Code MUE
- Device class
- Class 2
- Regulation
- 21 CFR 892.1715
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Stamford, CT, US
Recent devices under product code MUE
view allMore clearances from Fujifilm Medical Systems U.S.A, Inc.
view all- K171291 — FUJIFILM Bronchoscope Model EB-530P
- K171207 — FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
- K171463 — ASPIRE Bellus II
- K152257 — Fujifilm Duodenoscope Model ED-530XT
- K163624 — Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
Adverse events under product code MUE
product code MUE- Death
- 5
- Other
- 1
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.