# K946277: Tetrad 2300 E/U Ultrasoung Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Tetra Corp.
- Decided: Mar 15, 1996 after 444 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.
111 later devices descend from it; 2 cite it directly.
2 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K992505: Teratech, Model 2000 Imaging Imaging (1999), 109 descendants of its own
- K070907: Interson Usb Ultrasound Probe System (2007), 106 descendants of its own
- K102153: Mobius Ultrasound Imaging System (2011), 103 descendants of its own
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own
- K152899: Philips Lumify Diagnostic Ultrasound System (2015), 79 descendants of its own

Source page: https://510kreport.com/device/K946277
Methodology: https://510kreport.com/methodology