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FDA 510(k)

SAMSUNG RAYPAX SYSTEM

K-Number: K991537 · 1999-07-06

ApplicantSamsung Sds Co., Ltd.
Decision Date1999-07-06
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SAMSUNG RAYPAX SYSTEM 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 1999-07-06 under 510(k) number K991537. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAMSUNG RAYPAX SYSTEM?

SAMSUNG RAYPAX SYSTEM is a medical device that received FDA 510(k) clearance on 1999-07-06. The listed applicant is Samsung Sds Co., Ltd.. The 510(k) number is K991537.

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

SAMSUNG RAYPAX SYSTEM received FDA 510(k) clearance on 1999-07-06, under 510(k) number K991537.

Who is the listed applicant for SAMSUNG RAYPAX SYSTEM?

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 SYSTEM?

The FDA product code for SAMSUNG RAYPAX SYSTEM is LMD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 ARCHIVEK992112SAMSUNG RAYPAX FILM DIGITIZER

Related Devices (Code: LMD)

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.

K994329IIVS INTEGRATED IMAGE VIEWING STATIONTerarecon,Inc.K992698STENTOR, PAGEVIEWStentor, Inc.K992426RAYPAX WEB CLINICAL SYSTEMSamsung Sds Co., Ltd.K992352ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0Inteleradiology, Inc.K984000STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEMSurgical Navigation Technologies, Inc.K974707IMAGEQUESTVisual Med, Inc.

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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