FDA.reportPublic FDA data

510(k) K221309

Device
AI100 with Shonit
Applicant
Sigtuple Technologies Pvt. , Ltd.
510(k) number
K221309
Product code
JOY
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-19
Date received
2022-05-05
Regulation
864.5260
Classification name
Device, Automated Cell-Locating
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tathagato Rai Dastidar
Address
First Floor, L-162, 14th Cross Rd., Sector 6, Hsr Layout Bangalore IN 560102 560102

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.2025-06-27
K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.2022-05-03
K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB2020-10-16
K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.2020-10-02
K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceSysmex America, Inc.2018-10-30
K171315Advanced RBC ApplicationCellaVision AB2017-08-01
K102778CELLAVISION DM1200 WITH THE BODY FLUID APPLICTIONCellaVision AB2011-09-16
K092116EASYCELL CELL LOCATORMedica Corp.2010-05-12
K092868CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127CellaVision AB2009-11-20
K080595CELLAVISION DM96 WITH THE BODY FLUID APPLICATIONCellaVision AB2008-12-05
K071398SCANVIEW, MODEL SC-300Applied Spectral Imaging , Ltd.2007-10-04
K061602DUET SYSTEMBioview , Ltd.2007-01-23
K062755IKONISCOPE ONCOFISH BLADDER TEST SYSTEMIkonisys, Inc.2007-01-04
K061392IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEMIkonisys, Inc.2006-08-01
K052577IKONISCOPE FASTFISH AMNIO IMAGING SYSTEMIkonisys, Inc.2006-01-24