FDA.reportPublic FDA data

FUJIFILM

Primary DI
04547410446104
Brand
FUJIFILM
Company
FUJIFILM CORPORATION
Model
EX-0
Device description
The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states.This product may be used on all patients requiring endoscopic examination when using a Fujinon/FUJIFILM medical endoscope, video processor and light source together with monitor, recorder and various peripheral devices.The prospective clinical value of measurements made with OXEI has not been demonstrated in disease states.
Published
2021-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
GCJLaparoscope, General & Plastic Surgery
GSJAntiserum, Fluorescent, Francisella Tularensis
MUDOximeter, Tissue Saturation
NTNLed Light Source
NWBEndoscope, Accessories, Narrow Band Spectrum
PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
GSJAntiserum, Fluorescent, Francisella TularensisMicrobiology2
MUDOximeter, Tissue SaturationCardiovascular2
NTNLed Light SourceGastroenterology, Urology2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203717000Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton2021-06-30GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547410446104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547410446104045474104461044547410446104

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeterA mains electricity (AC-powered) photoelectric device that noninvasively calculates the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00There must be no condensation.
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+018002728465xxx@xxx.xxx

Regulatory Flags#

DUNS number
713565195
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04573596201404OASISMR-QFC-120XLOASIS QD Flexible Body Coil(XL) MR-QFC-120XL2026-05-29
04573596201411OASISMR-RFC-120OASIS RAPID Foot Coil MR-RFC-1202026-05-29
04573596201435OASISMR-CTL-120OASIS CTL Coil MR-CTL-1202026-05-29
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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

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Primary DI, Brand, Company table
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