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FDA-cleared K212654

Micro C Medical Imaging System, M01

OXOS Medical, Inc.

Authorized purpose: Micro C Medical Imaging System M01 is a handheld or portable general-purpose X-ray system for qualified clinicians to obtain diagnostic static or serial radiographic exposures of adult and pediatric extremities at the point of care; it is not a replacement for a full radiographic system with broader technique controls.

Modality
X-ray/Radiography
Anatomy
Adult and pediatric distal extremities
Decision
2022-02-04