# K992505: Teratech, Model 2000 Imaging Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: Nov 10, 1999 after 106 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903603 (1991). 3 ancestors in all.
109 later devices descend from it; 2 cite it directly.
2 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903603: Ultramark 9 Ultrasound System (UM 9), Advanced Technology Laboratories, Inc. (1991) Summary page 1.
- K914945: Diagnostic Ultrasound System Type 3535, Modified, Bruel & Kjaer Industri A/S (1992) Summary page 1.
- K946277: Tetrad 2300 E/U Ultrasoung Imaging System, Tetra Corp. (1996) Summary page 1.

## Most influential descendants
- 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
- K162549: Lumify Ultrasound System (2016), 43 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K992505
Methodology: https://510kreport.com/methodology