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FDA 510(k)

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

K-Number: K223794 · 2023-01-17

ApplicantCefla S.C.
Decision Date2023-01-17
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2023-01-17 under 510(k) number K223794. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is a medical device that received FDA 510(k) clearance on 2023-01-17. The listed applicant is Cefla S.C.. The 510(k) number is K223794.

When did hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS receive FDA 510(k) clearance?

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS received FDA 510(k) clearance on 2023-01-17, under 510(k) number K223794.

Who is the listed applicant for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?

The FDA 510(k) record lists Cefla S.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?

The FDA product code for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is OAS.

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Related Devices (Code: OAS)

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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