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510(k) DEN230034

X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application by Scopio Labs , Ltd. — Product Code SAL

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 22, 2024
Date Received
April 28, 2023
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Automated Cell Locating, Bone Marrow
Device Class
Class II
Regulation Number
864.5261
Review Panel
HE
Submission Type

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 patients being evaluated for hematologic diseases. The device assists operators to identify and classify each cell according to type.

Other clearances by Scopio Labs , Ltd.

  • K243144 — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (June 27, 2025)
  • K220013 — X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Applicatio (May 3, 2022)
  • K201301 — X100 with Full Field Peripheral Blood Smear (PBS) Application (October 2, 2020)