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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OLO
FDA UDI
DEKA M.E.L.A. SRL·08034108513218·Olo is a device which emits laser radiation wit...
Sight OLO
FDA UDI
S.D. SIGHT DIAGNOSTICS LTD·B787OLOU10·The Sight OLO device is a computer vision based...
Olo
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sight OLO
FDA 510(k)
FDA Class 2
·Hematology
Sight OLO
FDA 510(k)
FDA Class 2
·Hematology
OLO Control Kit
FDA UDI
S.D. SIGHT DIAGNOSTICS LTD·B787OCK10·An in vitro diagnostic control reagent designed...
OLO CBC Test Kit
FDA UDI
S.D. SIGHT DIAGNOSTICS LTD·B787TK10·A disposable cartridge and sample preparation t...
SURESHOT TARGETING I
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, INC.·Product code OLO·April 7, 2011
SURESHOT TARGETING I
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDS·April 10, 2012
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
FDA Enforcement
Class II
·Terminated·SIGHT DIAGNOSTICS LTD·September 29, 2021
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
FDA Recall
Terminated
·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·March 17, 2021
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
FDA Recall
Open, Classified
·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·June 14, 2022
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. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.
FDA Recall
Open, Classified
·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·January 20, 2022
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code NAY·January 11, 2019
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·September 30, 2025
INVICTUS
FDA Adverse Event
Malfunction
·ALPHATEC SPINE, INC.·Product code HXX·May 2, 2024
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
FDA Enforcement
Class II
·Ongoing·SIGHT DIAGNOSTICS LTD·August 3, 2022
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code NAY·January 11, 2019
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
FDA Enforcement
Class II
·Ongoing·SIGHT DIAGNOSTICS LTD·July 3, 2024
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
FDA Recall
Open, Classified
·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·May 13, 2024