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510(k) K221309

AI100 with Shonit by Sigtuple Technologies Pvt. , Ltd. — Product Code JOY

K221309 is an FDA 510(k) premarket notification submitted by Sigtuple Technologies Pvt. , Ltd. for the device "AI100 with Shonit". The FDA issued a decision of Substantially Equivalent on September 19, 2023. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2023
Date Received
May 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Automated Cell-Locating
Device Class
Class II
Regulation Number
864.5260
Review Panel
HE
Submission Type

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  • K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (October 30, 2018)
  • K171315 — Advanced RBC Application (August 1, 2017)
  • K102778 — CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION (September 16, 2011)
  • K092116 — EASYCELL CELL LOCATOR (May 12, 2010)
  • K092868 — CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 (November 20, 2009)
  • K080595 — CELLAVISION DM96 WITH THE BODY FLUID APPLICATION (December 5, 2008)

FDA data resources