ClearanceBrief
Company ยท JP

Fujifilm Corporation

FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.

71510(k) clearances (15 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
FDSGastroscope And Accessories, Flexible/Rigid15
EOQBronchoscope (Flexible Or Rigid)6
LLZSystem, Image Processing, Radiological6
FDFColonoscope And Accessories, Flexible/Rigid5
FDTDuodenoscope And Accessories, Flexible/Rigid5
LNHSystem, Nuclear Magnetic Resonance Imaging4
ODGEndoscopic Ultrasound System, Gastroenterology-Urology4
FDAEnteroscope And Accessories3
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology3
JAKSystem, X-Ray, Tomography, Computed3
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)3
GCJLaparoscope, General & Plastic Surgery2
QIHAutomated Radiological Image Processing Software2
QNPGastrointesinal Lesion Software Detection System2
FCXInsufflator, Automatic Carbon-Dioxide For Endoscope1
FEDEndoscopic Access Overtube, Gastroenterology-Urology1
ITXTransducer, Ultrasonic, Diagnostic1
IZHSystem, X-Ray, Mammographic1
KGEForceps, Biopsy, Electric1
MUEFull Field Digital, System, X-Ray, Mammographic1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 9, 2026K262902ECHELON Synergy
Fujifilm Corporation, JP
LNH
Sep 18, 2026K261229SCENARIA View Phase 6.0
Fujifilm Corporation, JP
JAK
Sep 16, 2026K261283APERTO Lucent MRI System
Fujifilm Corporation, JP
LNH
Sep 4, 2026K253836FCT iStream Phase 2
Fujifilm Corporation, JP
JAK
Aug 12, 2026K261170BA-004CC
Fujifilm Corporation, JP
ITX
Aug 7, 2026K260567EW10-EC02 Endoscopy Support Program
Fujifilm Corporation, JP
QNP
Jul 2, 2026K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01
Fujifilm Corporation, JP
FET
Jun 16, 2026K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T
Fujifilm Corporation, JP
EOQ
May 27, 2026K254075Synapse Lung Nodule AI
Fujifilm Corporation, JP
OEB
Apr 30, 2026K254189Synapse 3D Base Tools (V7.2)
Fujifilm Corporation, JP
QIH
Apr 6, 2026K253862APERTO Lucent MRI System
Fujifilm Corporation, JP
LNH
Mar 9, 2026K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
Fujifilm Corporation, JP
FDT
Feb 17, 2026K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
Fujifilm Corporation, JP
FDS
Feb 6, 2026K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
Fujifilm Corporation, JP
FDS
Dec 12, 2025K250863FUJIFILM Ultrasonic Endoscope EB-710US
Fujifilm Corporation, JP
EOQ
Sep 17, 2025K251386ECHELON Synergy
Fujifilm Corporation, JP
LNH
Jun 13, 2025K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000
Fujifilm Corporation, JP
EOQ
Jun 10, 2025K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
Fujifilm Corporation, JP
FDS
May 23, 2025K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
Fujifilm Corporation, JP
FDF
May 21, 2025K243762Synapse 3D Base Tools (V7.0)
Fujifilm Corporation, JP
QIH
May 20, 2025K250370SCENARIA View Phase 5.0
Fujifilm Corporation, JP
JAK
Apr 11, 2025K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
Fujifilm Corporation, JP
FET
Nov 1, 2024K243091Over-tube (TR-1108A)
Fujifilm Corporation, JP
FED
Oct 11, 2024K242779Hood (DH-083ST)
Fujifilm Corporation, JP
FDS
Sep 4, 2024K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
Fujifilm Corporation, JP
FDS
Dec 15, 2023K230751EW10-EC02 Endoscopy Support Program
Fujifilm Corporation, JP
QNP
Sep 8, 2023K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
Fujifilm Corporation, JP
FDF
Nov 10, 2022K221677Synapse 3D Base Tools v6.6
Fujifilm Corporation, JP
LLZ
Aug 19, 2022K221238FUJIFILM Ultrasonic Endoscope EG-740UT
Fujifilm Corporation, JP
ODG
Aug 4, 2022K221952Endoscope Model EG-580UT and Endoscope Model EG-580UR
Fujifilm Corporation, JP
ODG
Jun 3, 2022K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
Fujifilm Corporation, JP
ODG
May 27, 2022K212873Aspire Cristalle
Fujifilm Corporation, JP
MUE
Feb 4, 2022K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
Fujifilm Corporation, JP
KGE
Nov 8, 2021K212956FDR Cross (DR-XD 3000)
Fujifilm Corporation, JP
OWB
Oct 29, 2021K213195Balloon BS-3
Fujifilm Corporation, JP
FDA
Aug 19, 2021K212296Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
Fujifilm Corporation, JP
FDS
Apr 9, 2021K210162Endoscope Model EI-740D/S
Fujifilm Corporation, JP
FDS
Feb 9, 2021K203103Synapse 3D, Synapse 3D Base Tools v6.1
Fujifilm Corporation, JP
LLZ
Oct 30, 2020K203028FUJIFILM Distal End Cap
Fujifilm Corporation, JP
FDT
Aug 20, 2020K202130FUJIFILM Video Laparoscope
Fujifilm Corporation, JP
GCJ
Jul 6, 2020K200850Fujifilm Ultrasonic Processor
Fujifilm Corporation, JP
FDS
May 1, 2020K192286FUJIFILM EP-6000 Video Processor
Fujifilm Corporation, JP
FET
Apr 10, 2020K200668DR-ID 1200SDK System
Fujifilm Corporation, JP
MQB
Feb 20, 2020K192918Video Laparoscope, Video Processor, Light Source
Fujifilm Corporation, JP
GCJ
Dec 11, 2019K193123FUJIFILM Distal Cap Models 33-40
Fujifilm Corporation, JP
FDS
Nov 20, 2019K192664FUJIFILM Endoscope Model EC-760Z-V/L
Fujifilm Corporation, JP
FDF
Nov 12, 2019K192932FDR D-EVO III flat panel detector system
Fujifilm Corporation, JP
MQB
Nov 1, 2019K192440FDR SE Lite
Fujifilm Corporation, JP
MQB
Oct 18, 2019K191544Synapse 3D Blood Flow Analysis
Fujifilm Corporation, JP
LLZ
Sep 27, 2019K191747FUJIFILM Duodenoscope Model ED-580XT
Fujifilm Corporation, JP
FDT

Newest 50 of 71.

Latest recalls

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