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FDA 510(k)

S-70 PORTABLE DENTAL X-RAY SYSTEM

K-Number: K894935 · 1990-04-25

ApplicantLorad Medical Systems, Inc.
Decision Date1990-04-25
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S-70 PORTABLE DENTAL X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lorad Medical Systems, Inc.. It received FDA 510(k) clearance on 1990-04-25 under 510(k) number K894935. 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 S-70 PORTABLE DENTAL X-RAY SYSTEM?

S-70 PORTABLE DENTAL X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-04-25. The listed applicant is Lorad Medical Systems, Inc.. The 510(k) number is K894935.

When did S-70 PORTABLE DENTAL X-RAY SYSTEM receive FDA 510(k) clearance?

S-70 PORTABLE DENTAL X-RAY SYSTEM received FDA 510(k) clearance on 1990-04-25, under 510(k) number K894935.

Who is the listed applicant for S-70 PORTABLE DENTAL X-RAY SYSTEM?

The FDA 510(k) record lists Lorad Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-70 PORTABLE DENTAL X-RAY SYSTEM?

The FDA product code for S-70 PORTABLE DENTAL X-RAY SYSTEM is EHD.

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Other records listing Lorad Medical Systems, 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.

K921962LORAD DIGITAL SPOT MAMMOGRAPHYK922619DIGITIZER, MODEL # 3-000A-1518K913732MAMMOGRAPHIC X-RAY SYSTEMK913478RADIOGRAPHIC FILM MARKING SYSTEMK894643RT-125 ROUGH TERRAIN MOBILE X-RAY UNITK882875STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY

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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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