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FDA 510(k)

ACURAY DIGITAL X-RAY

K-Number: K963403 · 1997-01-02

ApplicantNew Image Industries, Inc.
Decision Date1997-01-02
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACURAY DIGITAL X-RAY is the device name listed in this FDA 510(k) record. The listed applicant is New Image Industries, Inc.. It received FDA 510(k) clearance on 1997-01-02 under 510(k) number K963403. 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 ACURAY DIGITAL X-RAY?

ACURAY DIGITAL X-RAY is a medical device that received FDA 510(k) clearance on 1997-01-02. The listed applicant is New Image Industries, Inc.. The 510(k) number is K963403.

When did ACURAY DIGITAL X-RAY receive FDA 510(k) clearance?

ACURAY DIGITAL X-RAY received FDA 510(k) clearance on 1997-01-02, under 510(k) number K963403.

Who is the listed applicant for ACURAY DIGITAL X-RAY?

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

What is the FDA product code for ACURAY DIGITAL X-RAY?

The FDA product code for ACURAY DIGITAL X-RAY 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing New Image Industries, 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.

K941716MICRODONTIC LENSK934002PERIO/ENDO LENS

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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