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FDA 510(k)

PACS EQUIPMENT

K-Number: K943994 · 1995-05-12

ApplicantRstar Image Management System
Decision Date1995-05-12
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PACS EQUIPMENT is the device name listed in this FDA 510(k) record. The listed applicant is Rstar Image Management System. It received FDA 510(k) clearance on 1995-05-12 under 510(k) number K943994. 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 PACS EQUIPMENT?

PACS EQUIPMENT is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Rstar Image Management System. The 510(k) number is K943994.

When did PACS EQUIPMENT receive FDA 510(k) clearance?

PACS EQUIPMENT received FDA 510(k) clearance on 1995-05-12, under 510(k) number K943994.

Who is the listed applicant for PACS EQUIPMENT?

The FDA 510(k) record lists Rstar Image Management System as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACS EQUIPMENT?

The FDA product code for PACS EQUIPMENT is LMD.

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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.K991537SAMSUNG RAYPAX SYSTEMSamsung Sds Co., Ltd.K984000STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEMSurgical Navigation Technologies, Inc.

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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