CHE SOFTWARE OPTION N6157330

GUDID 04953170431883

OLYMPUS MEDICAL SYSTEMS CORP.

Software upgrade/unlocking key

• Primary Device ID: 04953170431883
• NIH Device Record Key: c99c9386-a04e-4478-a2a4-2bc614b2290d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHE SOFTWARE OPTION
• Version Model Number: MAJ-2381
• Catalog Number: N6157330
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170431883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243502

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-11
• Device Publish Date: 2025-04-03

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

• 04953170431760 - EVIS EUS ENDOSCOPIC ULTRASOUND CENTER: 2025-04-11
• 04953170431883 - CHE SOFTWARE OPTION: 2025-04-11
• 04953170431883 - CHE SOFTWARE OPTION: 2025-04-11
• 04953170431890 - ELST SOFTWARE OPTION: 2025-04-11
• 04953170431906 - SWQ SOFTWARE OPTION: 2025-04-11
• 14953170466134 - Single Use Retrieval Basket V: 2025-04-02
• 14953170466141 - Single Use Retrieval Basket V: 2025-04-02
• 14953170466158 - Single Use Retrieval Basket V: 2025-04-02
• 14953170466165 - Single Use Retrieval Basket V: 2025-04-02