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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 the device name listed in this FDA 510(k) record. The listed applicant is Orfit Industries NV. It received FDA 510(k) clearance on 2016-11-22 under 510(k) 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. The listed applicant is Orfit Industries NV. The 510(k) number is K162355.

When did Raycast MammoRx Carbon Fibre Breast Board receive FDA 510(k) clearance?

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

Who is the listed applicant for Raycast MammoRx Carbon Fibre Breast Board?

The FDA 510(k) record lists Orfit Industries NV as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Orfit Industries NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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