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FDA 510(k)

ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT

K-Number: K925627 · 1993-10-08

ApplicantElscint, Inc.
Decision Date1993-10-08
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1993-10-08 under 510(k) number K925627. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT?

ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT is a medical device that received FDA 510(k) clearance on 1993-10-08. The listed applicant is Elscint, Inc.. The 510(k) number is K925627.

When did ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT receive FDA 510(k) clearance?

ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT received FDA 510(k) clearance on 1993-10-08, under 510(k) number K925627.

Who is the listed applicant for ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT?

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 ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT?

The FDA product code for ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT is IYO.

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Other records listing Elscint, Inc. as applicant

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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: IYO)

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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