FUJIFILM

Basic Information

• Brand Name: FUJIFILM
• Primary DI: 04547410541199
• Version / Model: EW10-EC02
• Company Name: FUJIFILM CORPORATION
• Labeler DUNS: 713565195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-16
• Public Version: 1
• Public Version Date: 2024-02-26
• Public Version Status: New
• Public Device Record Key: bf8eb466-1265-4f45-aed0-8dd245920e9c

Device Description

This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QNP	Gastrointesinal Lesion Software Detection System	Gastroenterology, Urology	876.1520	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64419	Endoscopic video image interpretive software	An interpretive software program intended to be used to analyse endoscopic video images to detect and localize suspected abnormalities (e.g., polyps) in real-time or post-endoscopy [traditional or capsule endoscopy]; it may in addition be intended to differentiate lesions and/or produce a probability score (e.g., neoplastic versus non-neoplastic). It is intended to be used on an off-the-shelf computerized device (e.g., laptop, smartphone), interface with an endoscopic video image processing unit, and will typically apply artificial intelligence (AI)/deep learning techniques to identify abnormalities and overlay visual flags on video images displayed by a monitor.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04547410541199	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K230751	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity