FDA 510(k) clearance · back to tracker

O-arm O2 Imaging System

Medtronic Navigation, Inc. cleared K240465 on 2024-06-21, decision: substantially equivalent

K-number

K240465

Sponsor

Medtronic Navigation, Inc.

Device

O-arm O2 Imaging System

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-06-21

Product code

OWB

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1650

Official FDA record

Open K240465on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.