Device, Automated Cell Locating, Bone Marrow
An automated cell-locating device for bone marrow aspirate is a prescription in vitro diagnostic device that automatically locates and presents images of hematopoietic cells on bone marrow aspirate smears from patients being evaluated for hematologic diseases, assisting operators in identifying and classifying each cell by type. It is classified as FDA Class II (510(k) required) under regulation 864.5261 in the Hematology specialty, with product code SAL. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SAL
- Device Class
- FDA class 2
- Regulation Number
- 864.5261
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230034 | X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application | Mar 22, 2024 | Unknown | Scopio Labs , Ltd. |