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FDA 510(k)

FONA Pan/Ceph

K-Number: K161131 · 2016-11-03

ApplicantFona S.R.L
Decision Date2016-11-03
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FONA Pan/Ceph 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 2016-11-03 under 510(k) number K161131. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FONA Pan/Ceph?

FONA Pan/Ceph is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Fona S.R.L. The 510(k) number is K161131.

When did FONA Pan/Ceph receive FDA 510(k) clearance?

FONA Pan/Ceph received FDA 510(k) clearance on 2016-11-03, under 510(k) number K161131.

Who is the listed applicant for FONA Pan/Ceph?

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 Pan/Ceph?

The FDA product code for FONA Pan/Ceph is MUH.

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.

K222274FONA XDCK213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephK212103StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2

Related Devices (Code: MUH)

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.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

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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