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FDA 510(k)

GYRES 2T PRESTIGE

K-Number: K945791 · 1995-09-19

ApplicantElscint, Inc.
Decision Date1995-09-19
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GYRES 2T PRESTIGE is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1995-09-19 under 510(k) number K945791. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYRES 2T PRESTIGE?

GYRES 2T PRESTIGE is a medical device that received FDA 510(k) clearance on 1995-09-19. The listed applicant is Elscint, Inc.. The 510(k) number is K945791.

When did GYRES 2T PRESTIGE receive FDA 510(k) clearance?

GYRES 2T PRESTIGE received FDA 510(k) clearance on 1995-09-19, under 510(k) number K945791.

Who is the listed applicant for GYRES 2T PRESTIGE?

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

What is the FDA product code for GYRES 2T PRESTIGE?

The FDA product code for GYRES 2T PRESTIGE is LNH.

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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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Related Devices (Code: LNH)

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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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