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FDA 510(k)

Portable X-ray System

K-Number: K172928 · 2018-03-16

ApplicantRolence Enterprise, Inc.
Decision Date2018-03-16
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Portable X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Rolence Enterprise, Inc.. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K172928. 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 Portable X-ray System?

Portable X-ray System is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Rolence Enterprise, Inc.. The 510(k) number is K172928.

When did Portable X-ray System receive FDA 510(k) clearance?

Portable X-ray System received FDA 510(k) clearance on 2018-03-16, under 510(k) number K172928.

Who is the listed applicant for Portable X-ray System?

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

What is the FDA product code for Portable X-ray System?

The FDA product code for Portable X-ray System is EHD.

Other records listing Rolence Enterprise, Inc. 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.

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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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