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FDA 510(k)

GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0

K-Number: K925985 · 1993-10-07

ApplicantElscint, Inc.
Decision Date1993-10-07
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1993-10-07 under 510(k) number K925985. 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 V-DIX & 2T-DIX SOFTWARE VERSION 3.0?

GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0 is a medical device that received FDA 510(k) clearance on 1993-10-07. The listed applicant is Elscint, Inc.. The 510(k) number is K925985.

When did GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0 receive FDA 510(k) clearance?

GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0 received FDA 510(k) clearance on 1993-10-07, under 510(k) number K925985.

Who is the listed applicant for GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0?

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 V-DIX & 2T-DIX SOFTWARE VERSION 3.0?

The FDA product code for GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0 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.

K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.K261283APERTO Lucent MRI SystemFujifilm CorporationK260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.K254250MagicScan-1.5, GreenMR Serenity 1.5TXingaoyi Medical Equipment Co.,LtdK253808AIR Recon DLGE Medical Systems

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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