ESI-5000

FDA 510(k) K935024 · Elscint, Inc.

Substantially Equivalent

510(k) numberK935024

Submission

Device name
ESI-5000
Applicant
Elscint, Inc.
Hackensack, NJ, US
Received
October 20, 1993
Decision date
June 12, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYN – System, Imaging, Pulsed Doppler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1550
Specialty
Radiology

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K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional Philips Ultrasound, LLC07/27/2026SE
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Questions and answers

When was ESI-5000 cleared by the FDA?

ESI-5000 (K935024) received a 510(k) decision of Substantially Equivalent on June 12, 1996, 966 days after the submission was received.

What is the product code of K935024?

The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.