DEVICE: Sight OLO (B787OLOU10)

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Device Record History
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Device Identifier (DI) Information
Sight OLO
OLO-U1
Not in Commercial Distribution

S.D. SIGHT DIAGNOSTICS LTD
B787OLOU10
HIBCC
September 30, 2024
1
534144402 *Terms of Use
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.
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
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Yes
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No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35476 Haematological cell analyser IVD
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity, cytometry, and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. Some types may also include measurement of haemoglobin.
Active false
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FDA Product Code

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Product Code Product Code Name
GKZ Counter, Differential Cell
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K190898 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
b3165bd1-63b2-4382-b090-d1f9eb242d31
November 14, 2024
4
February 09, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
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Customer Contact

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No Customer Contact currently defined
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