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FDA 510(k)

INTRAOS 70

K-Number: K031118 · 2003-07-08

ApplicantBlue X Imaging Srl
Decision Date2003-07-08
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTRAOS 70 is the device name listed in this FDA 510(k) record. The listed applicant is Blue X Imaging Srl. It received FDA 510(k) clearance on 2003-07-08 under 510(k) number K031118. 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 INTRAOS 70?

INTRAOS 70 is a medical device that received FDA 510(k) clearance on 2003-07-08. The listed applicant is Blue X Imaging Srl. The 510(k) number is K031118.

When did INTRAOS 70 receive FDA 510(k) clearance?

INTRAOS 70 received FDA 510(k) clearance on 2003-07-08, under 510(k) number K031118.

Who is the listed applicant for INTRAOS 70?

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

What is the FDA product code for INTRAOS 70?

The FDA product code for INTRAOS 70 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 Blue X Imaging Srl 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.

K031801PANTOS, MODELS: PANTOS 16, AND PANTOS DG

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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