510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201301Substantially Equivalent

X100 with Full Field Peripheral Blood Smear (PBS) Application

Scopio Labs Ltd., Tel Aviv, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201301 is the FDA 510(k) clearance record for X100 with Full Field Peripheral Blood Smear (PBS) Application, a class II device, cleared for Scopio Labs , Ltd. on under FDA product code JOY (Device, Automated Cell-Locating). FDA records list 4 510(k) clearances for Scopio Labs , Ltd., from to . As of , FDA records show no recalls naming K201301.

Clearance record

Decision date
Received
(140 days to decision)
Product code
JOY Device, Automated Cell-Locating
Regulation
21 CFR 864.5260
Device class
Class II
Review panel
Hematology
Applicant
Scopio Labs , Ltd. 11 Tiomkin St., 2nd Floor, Tel Aviv, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOY

Trailing 12 months

FDA records hold no clearances under product code JOY in the trailing twelve months.

FDA records show no clearances under product code JOY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260