510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230034Unknown

X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application

Scopio Labs Ltd., Tel-Aviv, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN230034 is the FDA 510(k) clearance record for X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application, a class II device, cleared for Scopio Labs , Ltd. on under FDA product code SAL (Device, Automated Cell Locating, Bone Marrow). FDA's definition for product code SAL reads: "An automated cell-locating device for bone marrow aspirate is an in vitro diagnostic device intended for prescription use that automatically locates and presents images of hematopoietic cells on a bone marrow aspirate smear obtained from...". FDA records list 4 510(k) clearances for Scopio Labs , Ltd., from to . As of , FDA records show no recalls naming DEN230034.

Clearance record

Decision date
Received
(329 days to decision)
Product code
SAL Device, Automated Cell Locating, Bone Marrow
Regulation
21 CFR 864.5261
Device class
Class II
Review panel
Hematology
Applicant
Scopio Labs , Ltd. 10 Hasharon St., Tel-Aviv, IL
Third party review
No

Clearances, product code SAL

Trailing 12 months

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

FDA records show no clearances under product code SAL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SAL, 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