X100 Digital Scanner

GUDID 07290018417034

X100 Digital Scanner (Complete Unit)

SCOPIO LABS LTD

Cell morphology analyser IVD, automated/semi-automated

• Primary Device ID: 07290018417034
• NIH Device Record Key: 1878b2fe-4d46-489a-b915-05675c732b31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X100 Digital Scanner
• Version Model Number: SC-SYS-00003
• Company DUNS: 600369986
• Company Name: SCOPIO LABS LTD
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290018417034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201301
• Premarket Notification: K220013

FDA Product Code

• JOY: Device, Automated Cell-Locating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-06-30
• Device Publish Date: 2022-12-30

Devices Manufactured by SCOPIO LABS LTD

• 07290018417034 - X100 Digital Scanner: 2025-06-30X100 Digital Scanner (Complete Unit)
• 07290018417034 - X100 Digital Scanner: 2025-06-30 X100 Digital Scanner (Complete Unit)
• 07290018417072 - X100 Processing Unit (Complete Unit): 2025-06-30 The processing unit connected to the X100 digital scanner
• 07290018417096 - X100HT Digital Scanner: 2025-06-30 X100HT Digital Scanner (Complete Unit)
• 07290018417126 - X100HT Processing Unit: 2025-06-30 X100HT Processing Unit (Complete Unit)
• 07290018417133 - X100 with Full Field Peripheral Blood Smear Application: 2025-06-30 X100 with Processing Unit and FF-PBS application. Includes: - X100 Scanner - X100 Processing Unit - X100 User Maintenance Kit
• 07290018417140 - X100HT with Full Field Peripheral Blood Smear (PBS) Application: 2025-06-30 X100HT with Processing Unit and FF-PBS application. Includes: - X100HT Scanner - X100HT Processing Unit - X100HT User Maintenanc
• 07290118610892 - X100HT System: 2024-12-09 X100HT with Processing Unit and a Maintenance Kit. Includes: - X100HT Scanner - X100HT Processing Unit - X100HT User Maintenance