FDA 510(k)

ESI-5000

K-Number: K935024 · 1996-06-12

Decision Date1996-06-12

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ESI-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1996-06-12 under 510(k) number K935024. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESI-5000?

ESI-5000 is a medical device that received FDA 510(k) clearance on 1996-06-12. The listed applicant is Elscint, Inc.. The 510(k) number is K935024.

When did ESI-5000 receive FDA 510(k) clearance?

ESI-5000 received FDA 510(k) clearance on 1996-06-12, under 510(k) number K935024.

Who is the listed applicant for ESI-5000?

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 ESI-5000?

The FDA product code for ESI-5000 is IYN.

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 GLORY K982060VOLUMAX CT IMAGING SYSTEM K974344CT SCOPE K980306GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP K974614GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 K9725922T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)

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Related Devices (Code: IYN)

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.