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FDA 510(k)

Raycast MammoRx Carbon Fibre Breast Board

K-Number: K162355 · 2016-11-22

ApplicantOrfit Industries NV
Decision Date2016-11-22
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Raycast MammoRx Carbon Fibre Breast Board is a medical device manufactured by Orfit Industries NV. It received FDA 510(k) clearance on 2016-11-22 under approval number K162355. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Raycast MammoRx Carbon Fibre Breast Board?

Raycast MammoRx Carbon Fibre Breast Board is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Orfit Industries NV. The 510(k) number is K162355.

When was Raycast MammoRx Carbon Fibre Breast Board approved by the FDA?

Raycast MammoRx Carbon Fibre Breast Board received FDA 510(k) clearance on 2016-11-22, under approval number K162355.

What company makes Raycast MammoRx Carbon Fibre Breast Board?

Raycast MammoRx Carbon Fibre Breast Board is manufactured by Orfit Industries NV.

What is the FDA product code for Raycast MammoRx Carbon Fibre Breast Board?

The FDA product code for Raycast MammoRx Carbon Fibre Breast Board is IYE.

Related Clinical Trials

NCT07527468 HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving Surgery NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41034609 Influence of geometry, reinforcement, and sterilisation on the dimensional accuracy of additively manufactured carbon fibre-reinforced nylon composites. Scientific reports (2025)

Other Devices by Orfit Industries NV

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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.

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