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Regulatory filing

K242575 (us_fda)

FDA 510(k) K242575 for Brain Navi NaoTrac S neurosurgical robot. Stereotaxic guiding procedures.

fda 510k · cleared · decided 2025-05-23


Machine-readable surfaces

Key facts

Jurisdiction
us_fda
Filing type
fda 510k
Status
cleared
Filing number
K242575
Filing date
2025-05-23
Decision date
2025-05-23
Verification posture
verified

Applicant

Brain Navi

Covered models (1)

Sources (1)

  1. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242575.pdf

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Identity

caf3fb98-610a-4c89-a287-df4ffa53c453