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FDA 510(k)

SAMSUNG RAYPAX FILM DIGITIZER

K-Number: K992112 · 1999-09-09

ApplicantSamsung Sds Co., Ltd.
Decision Date1999-09-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SAMSUNG RAYPAX FILM DIGITIZER is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Sds Co., Ltd.. It received FDA 510(k) clearance on 1999-09-09 under 510(k) number K992112. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAMSUNG RAYPAX FILM DIGITIZER?

SAMSUNG RAYPAX FILM DIGITIZER is a medical device that received FDA 510(k) clearance on 1999-09-09. The listed applicant is Samsung Sds Co., Ltd.. The 510(k) number is K992112.

When did SAMSUNG RAYPAX FILM DIGITIZER receive FDA 510(k) clearance?

SAMSUNG RAYPAX FILM DIGITIZER received FDA 510(k) clearance on 1999-09-09, under 510(k) number K992112.

Who is the listed applicant for SAMSUNG RAYPAX FILM DIGITIZER?

The FDA 510(k) record lists Samsung Sds Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAMSUNG RAYPAX FILM DIGITIZER?

The FDA product code for SAMSUNG RAYPAX FILM DIGITIZER is LLZ.

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Other records listing Samsung Sds Co., Ltd. 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.

K002062SAMSUNG 10DR IMPLANT SYSTEMK992426RAYPAX WEB CLINICAL SYSTEMK992306SAMSUNG RAYPAX DISPLAY WORKSTATIONK992131SAMSUNG RAYPAX LONG TERM ARCHIVEK991537SAMSUNG RAYPAX SYSTEM

Related Devices (Code: LLZ)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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