Fast Warm - NX— 510(k) K250445

Substantially Equivalent

Fujifilm Irvine Scientific

FDA 510(k) clearance K250445 for Fast Warm - NX, Substantially Equivalent on 2025-09-12. Applicant: Fujifilm Irvine Scientific.

Clearance details

Applicant: Fujifilm Irvine Scientific
Product code: Code MQL
Advisory panel: Obstetrics/Gynecology
Date received: 2025-02-14
Decision date: 2025-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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