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FDA 510(k)

EVA DIGITAL DENTAL X-RAY SYSTEM

K-Number: K030647 · 2003-03-20

ApplicantAfp Imaging Corp.
Decision Date2003-03-20
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EVA DIGITAL DENTAL X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Afp Imaging Corp.. It received FDA 510(k) clearance on 2003-03-20 under 510(k) number K030647. 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 EVA DIGITAL DENTAL X-RAY SYSTEM?

EVA DIGITAL DENTAL X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-03-20. The listed applicant is Afp Imaging Corp.. The 510(k) number is K030647.

When did EVA DIGITAL DENTAL X-RAY SYSTEM receive FDA 510(k) clearance?

EVA DIGITAL DENTAL X-RAY SYSTEM received FDA 510(k) clearance on 2003-03-20, under 510(k) number K030647.

Who is the listed applicant for EVA DIGITAL DENTAL X-RAY SYSTEM?

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

What is the FDA product code for EVA DIGITAL DENTAL X-RAY SYSTEM?

The FDA product code for EVA DIGITAL DENTAL X-RAY SYSTEM is EHD.

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Other records listing Afp Imaging Corp. 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.

K123419EVA SELECT DIGITAL DENTAL IMAGING SYSTEMK072357NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEMK041120EV APAN DIGITAL, MODEL K1VSM2000K014144EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804K013176MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWAREK974619SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM

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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.

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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