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FDA 510(k)

SENS-A-RAY

K-Number: K923067 · 1992-11-27

ApplicantRegam Medical Systems
Decision Date1992-11-27
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SENS-A-RAY is the device name listed in this FDA 510(k) record. The listed applicant is Regam Medical Systems. It received FDA 510(k) clearance on 1992-11-27 under 510(k) number K923067. 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 SENS-A-RAY?

SENS-A-RAY is a medical device that received FDA 510(k) clearance on 1992-11-27. The listed applicant is Regam Medical Systems. The 510(k) number is K923067.

When did SENS-A-RAY receive FDA 510(k) clearance?

SENS-A-RAY received FDA 510(k) clearance on 1992-11-27, under 510(k) number K923067.

Who is the listed applicant for SENS-A-RAY?

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

What is the FDA product code for SENS-A-RAY?

The FDA product code for SENS-A-RAY is EHD.

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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