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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 a medical device manufactured by Fona S.R.L. It received FDA 510(k) clearance on 2016-11-03 under approval 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. It is manufactured by Fona S.R.L. The 510(k) number is K161131.

When was FONA Pan/Ceph approved by the FDA?

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

What company makes FONA Pan/Ceph?

FONA Pan/Ceph is manufactured by Fona S.R.L.

What is the FDA product code for FONA Pan/Ceph?

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

Other Devices by Fona S.R.L

K212103StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 K222274FONA XDC K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

Related Devices (Code: MUH)

K162619I View and Imagen SensorTrident S.R.L K162585SuniIQ Digital Radiography SystemSuni Medical Imaging, Inc. K160788RIOScan (RPS500)Ray Co., Ltd. K160386ReadeR, VieweR, QuickScan PSPTrident S.R.L K153144TIO-H DIGITAL RADIOGRAPHY SENSORDenttio, Inc. K173646FS ErgoPalodex Group OY

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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