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FDA 510(k)

KaVo NOMAD Pro 2 Handheld X-ray System

K-Number: K173319 · 2017-11-16

ApplicantAribex
Decision Date2017-11-16
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KaVo NOMAD Pro 2 Handheld X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Aribex. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K173319. 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 KaVo NOMAD Pro 2 Handheld X-ray System?

KaVo NOMAD Pro 2 Handheld X-ray System is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Aribex. The 510(k) number is K173319.

When did KaVo NOMAD Pro 2 Handheld X-ray System receive FDA 510(k) clearance?

KaVo NOMAD Pro 2 Handheld X-ray System received FDA 510(k) clearance on 2017-11-16, under 510(k) number K173319.

Who is the listed applicant for KaVo NOMAD Pro 2 Handheld X-ray System?

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

What is the FDA product code for KaVo NOMAD Pro 2 Handheld X-ray System?

The FDA product code for KaVo NOMAD Pro 2 Handheld X-ray System is EHD.

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

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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