Sight OLO

GUDID B787OLOU10

The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion.

S.D. SIGHT DIAGNOSTICS LTD

Haematological cell analyser IVD, automated Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD

• Primary Device ID: B787OLOU10
• NIH Device Record Key: b3165bd1-63b2-4382-b090-d1f9eb242d31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sight OLO
• Version Model Number: OLO-U1
• Company DUNS: 534144402
• Company Name: S.D. SIGHT DIAGNOSTICS 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: false
• Serial Number: true
• 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
HIBCC	B787OLOU10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190898

FDA Product Code

• GKZ: Counter, Differential Cell

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: 2020-02-17
• Device Publish Date: 2020-02-09

Devices Manufactured by S.D. SIGHT DIAGNOSTICS LTD

• B787OCK10 - OLO Control Kit: 2020-05-12 An in vitro diagnostic control reagent designed to monitor values on the Sight OLO multi-parameter hematology analyser.
• B787OLOU10 - Sight OLO: 2020-02-17The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion.
• B787OLOU10 - Sight OLO: 2020-02-17 The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms fo
• B787TK10 - OLO CBC Test Kit: 2020-02-17 A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.