3DXR
K-Number: K243446 · 2025-02-25
ApplicantGE Medical Systems SCS
Decision Date2025-02-25
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
3DXR is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2025-02-25 under approval number K243446. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 3DXR?
3DXR is a medical device that received FDA 510(k) clearance on 2025-02-25. It is manufactured by GE Medical Systems SCS. The 510(k) number is K243446.
When was 3DXR approved by the FDA?
3DXR received FDA 510(k) clearance on 2025-02-25, under approval number K243446.
What company makes 3DXR?
3DXR is manufactured by GE Medical Systems SCS.
What is the FDA product code for 3DXR?
The FDA product code for 3DXR is OWB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.