INFINITT DPS

GUDID 08809278790291

INFINITT Healthcare Co.,Ltd.

Histology/cytology/microbiology image-analysis interpretive software IVD

• Primary Device ID: 08809278790291
• NIH Device Record Key: 26641f60-714f-47b4-bc79-e316546eea90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITT DPS
• Version Model Number: INFINITT DPS
• Company DUNS: 688319156
• Company Name: INFINITT Healthcare Co.,Ltd.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809278790291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243449

FDA Product Code

• QKQ: Digital Pathology Image Viewing And Management Software

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: 2026-02-06
• Device Publish Date: 2026-01-29

Devices Manufactured by INFINITT Healthcare Co.,Ltd.

• 08809278790291 - INFINITT DPS: 2026-02-06
• 08809278790291 - INFINITT DPS: 2026-02-06
• 08809278790000 - STARPACS: 2023-10-18
• 08809278790062 - INFINITT Cardiology PACS: 2023-10-18
• 08809278790079 - Xelis: 2023-10-18
• 08809278790086 - Xelis 3D: 2023-10-18
• 08809278790093 - Xelis Fusion: 2023-10-18
• 08809278790109 - Xelis Cardiac: 2023-10-18
• 08809278790116 - Xelis Dental: 2023-10-18