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FDA 510(k)

FONA XDC

K-Number: K222274 · 2022-08-23

ApplicantFona S.R.L
Decision Date2022-08-23
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FONA XDC is the device name listed in this FDA 510(k) record. The listed applicant is Fona S.R.L. It received FDA 510(k) clearance on 2022-08-23 under 510(k) number K222274. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FONA XDC?

FONA XDC is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Fona S.R.L. The 510(k) number is K222274.

When did FONA XDC receive FDA 510(k) clearance?

FONA XDC received FDA 510(k) clearance on 2022-08-23, under 510(k) number K222274.

Who is the listed applicant for FONA XDC?

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

What is the FDA product code for FONA XDC?

The FDA product code for FONA XDC is EHD.

Other records listing Fona S.R.L 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.

K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephK212103StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2K161131FONA Pan/Ceph

Related Devices (Code: EHD)

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.

K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )Guilin Woodpecker Medical Instrument Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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