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FDA 510(k)

VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.

K-Number: K974077 · 1998-01-20

ApplicantJ. Morita USA, Inc.
Decision Date1998-01-20
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 1998-01-20 under 510(k) number K974077. 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 VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.?

VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. is a medical device that received FDA 510(k) clearance on 1998-01-20. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K974077.

When did VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. receive FDA 510(k) clearance?

VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. received FDA 510(k) clearance on 1998-01-20, under 510(k) number K974077.

Who is the listed applicant for VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.?

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

What is the FDA product code for VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.?

The FDA product code for VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. is EHD.

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Other records listing J. Morita USA, Inc. as applicant

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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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