Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

I View and Imagen Sensor

K-Number: K162619 · 2016-11-04

ApplicantTrident S.R.L
Decision Date2016-11-04
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

I View and Imagen Sensor is a medical device manufactured by Trident S.R.L. It received FDA 510(k) clearance on 2016-11-04 under approval number K162619. 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 I View and Imagen Sensor?

I View and Imagen Sensor is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Trident S.R.L. The 510(k) number is K162619.

When was I View and Imagen Sensor approved by the FDA?

I View and Imagen Sensor received FDA 510(k) clearance on 2016-11-04, under approval number K162619.

What company makes I View and Imagen Sensor?

I View and Imagen Sensor is manufactured by Trident S.R.L.

What is the FDA product code for I View and Imagen Sensor?

The FDA product code for I View and Imagen Sensor is MUH.

Other Devices by Trident S.R.L

K160386ReadeR, VieweR, QuickScan PSP K182206RiX70 DC K200625I-View Gold and Imagen Gold Dental Sensors K222666X-View 3D Pan/X-View 2D Pan

Related Devices (Code: MUH)

K162585SuniIQ Digital Radiography SystemSuni Medical Imaging, Inc. K161131FONA Pan/CephFona S.R.L 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.

↑