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FDA 510(k)

DYNEX ULTRASOUND DIAGNOSTIC SCANNER

K-Number: K827744 · 1982-10-07

ApplicantElscint, Inc.
Decision Date1982-10-07
Product Code
DecisionSubstantially Equivalent

Device Summary

DYNEX ULTRASOUND DIAGNOSTIC SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1982-10-07 under 510(k) number K827744. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNEX ULTRASOUND DIAGNOSTIC SCANNER?

DYNEX ULTRASOUND DIAGNOSTIC SCANNER is a medical device that received FDA 510(k) clearance on 1982-10-07. The listed applicant is Elscint, Inc.. The 510(k) number is K827744.

When did DYNEX ULTRASOUND DIAGNOSTIC SCANNER receive FDA 510(k) clearance?

DYNEX ULTRASOUND DIAGNOSTIC SCANNER received FDA 510(k) clearance on 1982-10-07, under 510(k) number K827744.

Who is the listed applicant for DYNEX ULTRASOUND DIAGNOSTIC SCANNER?

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

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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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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