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FDA 510(k)

EMINEX LS-8 SYSTEM

K-Number: K837181 · 1983-04-01

ApplicantElscint, Inc.
Decision Date1983-04-01
Product Code
DecisionSubstantially Equivalent

Device Summary

EMINEX LS-8 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1983-04-01 under 510(k) number K837181. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMINEX LS-8 SYSTEM?

EMINEX LS-8 SYSTEM is a medical device that received FDA 510(k) clearance on 1983-04-01. The listed applicant is Elscint, Inc.. The 510(k) number is K837181.

When did EMINEX LS-8 SYSTEM receive FDA 510(k) clearance?

EMINEX LS-8 SYSTEM received FDA 510(k) clearance on 1983-04-01, under 510(k) number K837181.

Who is the listed applicant for EMINEX LS-8 SYSTEM?

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

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Other records listing Elscint, 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.

K983313ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORYK982060VOLUMAX CT IMAGING SYSTEMK974344CT SCOPEK980306GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EPK974614GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102K9725922T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)

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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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