FDA 510(k) clearance · back to tracker

ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)

Medphoton GmbH cleared K234067 on 2025-03-28, decision: substantially equivalent

K-number

K234067

Sponsor

Medphoton GmbH

Device

ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-03-28

Product code

OWB

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1650

Official FDA record

Open K234067on 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.