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FDA 510(k)

GYREX 2T-PRESTIGE

K-Number: K970005 · 1997-03-28

ApplicantElscint, Inc.
Decision Date1997-03-28
Product CodeLNI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GYREX 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 1997-03-28 under 510(k) number K970005. The device is classified under product code LNI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYREX 2T-PRESTIGE?

GYREX 2T-PRESTIGE is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Elscint, Inc.. The 510(k) number is K970005.

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

GYREX 2T-PRESTIGE received FDA 510(k) clearance on 1997-03-28, under 510(k) number K970005.

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

The FDA product code for GYREX 2T-PRESTIGE is LNI.

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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: LNI)

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.

K093044OASIS MRI SYSTEMHitachi Medical Systems America, Inc.K071506ECHELON SPECTROSCOPY PACKAGEHitachi Medical Systems America, Inc.K011604PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRIGe Medical Systems, Inc.K010129EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3Toshiba America Medical Systems, In.CK003575MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEMGE Medical SystemsK991568MR SPECTROSCOPY PACKAGEPhilips Medical Systems (Cleveland), Inc.

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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