O-arm O2 Imaging System

by Medtronic, Inc. 2 variants

510(k) K200074

O-arm O2 Imaging System is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K200074 on 24 Apr 2020, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K200074↗

FDA record

Trust

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK200074	Date24 Apr 2020Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K200074

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K200074
FDA product code: OWB

Device class: Class II
Regulation: 21 CFR Part 892.1650
Advisory committee: Radiology
FDA decision: SESE Substantially Equivalent

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