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FDA 510(k)

PORTABLE X-RAY SYSTEM

K-Number: K103600 · 2011-04-08

ApplicantDigimed Corporation
Decision Date2011-04-08
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 Digimed Corporation. It received FDA 510(k) clearance on 2011-04-08 under 510(k) number K103600. 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 2011-04-08. The listed applicant is Digimed Corporation. The 510(k) number is K103600.

When did PORTABLE X-RAY SYSTEM receive FDA 510(k) clearance?

PORTABLE X-RAY SYSTEM received FDA 510(k) clearance on 2011-04-08, under 510(k) number K103600.

Who is the listed applicant for PORTABLE X-RAY SYSTEM?

The FDA 510(k) record lists Digimed Corporation 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.

Related Clinical Trials

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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Other records listing Digimed Corporation 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.

K082167PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX

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.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.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.

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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