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FDA 510(k)

HEAD AND NECK COIL FOR THE GYREX 2T-DLX

K-Number: K943320 · 1994-11-29

ApplicantElscint, Inc.
Decision Date1994-11-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEAD AND NECK COIL FOR THE GYREX 2T-DLX is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1994-11-29 under 510(k) number K943320. 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 HEAD AND NECK COIL FOR THE GYREX 2T-DLX?

HEAD AND NECK COIL FOR THE GYREX 2T-DLX is a medical device that received FDA 510(k) clearance on 1994-11-29. The listed applicant is Elscint, Inc.. The 510(k) number is K943320.

When did HEAD AND NECK COIL FOR THE GYREX 2T-DLX receive FDA 510(k) clearance?

HEAD AND NECK COIL FOR THE GYREX 2T-DLX received FDA 510(k) clearance on 1994-11-29, under 510(k) number K943320.

Who is the listed applicant for HEAD AND NECK COIL FOR THE GYREX 2T-DLX?

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 HEAD AND NECK COIL FOR THE GYREX 2T-DLX?

The FDA product code for HEAD AND NECK COIL FOR THE GYREX 2T-DLX 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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