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FDA 510(k)

GYREX 2T-SGR

K-Number: K935549 · 1994-08-24

ApplicantElscint, Inc.
Decision Date1994-08-24
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GYREX 2T-SGR is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1994-08-24 under 510(k) number K935549. 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 GYREX 2T-SGR?

GYREX 2T-SGR is a medical device that received FDA 510(k) clearance on 1994-08-24. The listed applicant is Elscint, Inc.. The 510(k) number is K935549.

When did GYREX 2T-SGR receive FDA 510(k) clearance?

GYREX 2T-SGR received FDA 510(k) clearance on 1994-08-24, under 510(k) number K935549.

Who is the listed applicant for GYREX 2T-SGR?

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 GYREX 2T-SGR?

The FDA product code for GYREX 2T-SGR 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)

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

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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