# K935024: ESI-5000

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Jun 12, 1996 after 966 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ESI-1000: named in the summary without a submission number
- (no number) ESI-2000: named in the summary without a submission number
- (no number) ESI-3000: named in the summary without a submission number
- (no number) 128 XP: named in the summary without a submission number
- (no number) UM-9: named in the summary without a submission number

## Most influential descendants
- K972973: Perception Inc. GPS-Tuv Diagnostic Ultrasound System (1997), 2 descendants of its own
- K981834: Perception Inc, GPS-6TBMD Diagnostic Ultrasound System (1998), 0 descendants of its own
- K974880: Perception GPS-RST Diagnostic Ultrasound System (1998), 0 descendants of its own

## Indications for use
The ESI-5000 ultrasound system main applications are in general radiology, obstetrics/gynecology, cardiology, and peripheral vessel 2D imaging, spectral Doppler analysis, and color Doppler imaging.

Source page: https://510kreport.com/device/K935024
Methodology: https://510kreport.com/methodology