FDA 510(k) Applications Submitted by FUJIFILM Healthcare Americas Corporation

FDA 510(k) Number	Submission Date	Device Name	Applicant
K240075	01/10/2024	FUJIFILM Endoscope Model EB-710XT	Fujifilm Healthcare Americas Corporation
K231574	05/31/2023	Scenaria View 4.2	Fujifilm Healthcare Americas Corporation
K231666	06/07/2023	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	Fujifilm Healthcare Americas Corporation
K231941	06/30/2023	ARIETTA x10	Fujifilm Healthcare Americas Corporation
K232314	08/02/2023	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	Fujifilm Healthcare Americas Corporation
K233321	09/29/2023	Double Balloon Endoscope EN-840T, Over-tube TS-1214C	FUJIFILM Healthcare Americas Corporation
K233583	11/07/2023	FCT iSTREAM Phase 1	FUJIFILM Healthcare Americas Corporation
K233687	11/17/2023	ECHELON Synergy V10.0	Fujifilm Healthcare Americas Corporation
K233629	11/13/2023	APERTO Lucent MRI System	FUJIFILM Healthcare Americas Corporation
K230752	03/17/2023	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	Fujifilm Healthcare Americas Corporation
K243647	11/26/2024	Synapse PACS (7.5)	FUJIFILM Healthcare Americas Corporation