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FDA 510(k)

HYPERION X9

K-Number: K123381 · 2013-05-10

ApplicantCefla S.C.
Decision Date2013-05-10
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HYPERION X9 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 2013-05-10 under 510(k) number K123381. 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?

HYPERION X9 is a medical device that received FDA 510(k) clearance on 2013-05-10. The listed applicant is Cefla S.C.. The 510(k) number is K123381.

When did HYPERION X9 receive FDA 510(k) clearance?

HYPERION X9 received FDA 510(k) clearance on 2013-05-10, under 510(k) number K123381.

Who is the listed applicant for HYPERION X9?

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?

The FDA product code for HYPERION X9 is OAS.

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Other records listing Cefla S.C. 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: 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.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

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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