FDA.reportPublic FDA data

FUJIFILM

Primary DI
04547410480269
Brand
FUJIFILM
Company
FUJIFILM CORPORATION
Model
VS-1000
Device description
This product is a non-sterile, reusable display device designed to display live image data from FUJIFILM single-use endoscope.
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250550000
K251861000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250550000FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation2026-02-17FDS
K251861000FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000Fujifilm Corporation2026-03-09FDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547410480269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547410480269045474104802694547410480269

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00No dew condensation
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
713565195
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547410529128FUJIFILMEG-S100XT2026-05-22
04573596200865APERTO LucentMR-JCR-82Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT 2026-05-22
04573596200889APERTO LucentMR-JC-81Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200896APERTO LucentMR-JCR-83Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT 2026-05-22
04573596200902APERTO LucentMR-CSC-81C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200940APERTO LucentMR-QWC-81Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter2026-05-22
04573596200964APERTO LucentMR-MSC-81Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E2026-05-22
04573596200971APERTO LucentMR-QRC-81Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E2026-05-22
04573596201480APERTO LucentMR-QHC-81RQD Head coil R MR-QHC-81R for APERTO Lucent2026-05-22
04573596201497APERTO LucentMR-QKC-83RQD Knee coil R MR-QKC-83R for APERTO Lucent2026-05-22
04573596201503APERTO LucentMR-IBC-83Open body coil MR-IBC-83 for APERTO Lucent/APERTO 2026-05-22
04573596202210APERTO LucentMR-QFC-82NFlexible Body coil N(M) MR-QFC-82N for APERTO Luce2026-05-22
04573596202227APERTO LucentMR-QFC-83NFlexible Body coil N(L) MR-QFC-83N for APERTO Luce2026-05-22
04547410571134FDR AQRODR-XD 1000 MBL ES US E2026-03-20
14547410566250FUJIFILMDH-084STR2026-02-27
14547410566298FUJIFILMDH-094STR2026-02-27
14547410566335FUJIFILMDH-104STR2026-02-27
14547410566373FUJIFILMDH-114STR2026-02-27
14547410566410FUJIFILMDH-124STR2026-02-27
14547410566458FUJIFILMDH-134STR2026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047788553GimmiGimmi GmbHFET2026-03-04
04049047788577GimmiGimmi GmbHFET2026-03-04
04049047788584GimmiGimmi GmbHFET2026-03-04
06971176282399EviewZhuhai Pusen Medical Technology Co, LtdFET2026-01-22
05391533810095ProVee Video Processing UnitPROVERUM LIMITEDFET2025-12-02
04250480104200NASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04547410513790FUJIFILMFUJIFILM CORPORATIONFET2025-05-31
049531704302684K Camera HeadOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170433313VISERA ELITE III VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170433412VISERA ELITE III LED LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170445453OTV-S700 UPGRADE PACK 3DOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04048551432259NAKarl Storz GmbH & Co. KGFET2025-03-27
04049047788539GimmiGimmi GmbHFET2025-03-20
04049047788546GimmiGimmi GmbHFET2025-03-20
04049047788560GimmiGimmi GmbHFET2025-03-20
04250480101711NASCHÖLLY FIBEROPTIC GmbHFET2024-12-03
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.FET2024-11-14
00810024670277Dragonfly Digital ControllerCENTERPOINT SYSTEMS LLCFET2024-07-22
04250480109076NASCHÖLLY FIBEROPTIC GmbHFET2023-10-30
04250480109083NASCHÖLLY FIBEROPTIC GmbHFET2023-10-30
04961333083701PENTAXHOYA CORPORATIONFET2023-07-31
06973786290139lmaging Processor System (lncluding Light Source)Shanghai SeeGen Photoelectric Technology Co., LtdFET2023-07-26
04953170136528ULTRASONIC CABLE AOLYMPUS MEDICAL SYSTEMS CORP.FET2023-06-16
04953170136634PROBE DRIVING UNITOLYMPUS MEDICAL SYSTEMS CORP.FET2023-06-16
04953170437519AIR/WATER VALVE FOR CHF-B20OLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22
04953170437724Channel plugOLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22
04953170437731Injection tubeOLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22
04953170437748Water-resistant capOLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22
04953170437922Channel Connection TubeOLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22
04953170437946WASHING TUBEOLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22