# K012191: Teratech Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: Jul 26, 2001 after 13 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
Longest line of descent: 2 generations back to K934915 (1994). 2 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991805: Aspen Ultrasound with Freestyle Imaging Option, Acuson Corp. (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K097367: Acuson Sequoia™ Ultrasound System and Harmonic Imaging. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K030191: Terason Model 2000/Bas Portable Ultrasound System (2003), 24 descendants of its own
- K032333: Cryocare CS Surgical System (2003), 13 descendants of its own
- K050347: Modification to Cryocare CS Surgical System (2005), 12 descendants of its own
- K060279: Cryocare CS Surgical System (2006), 9 descendants of its own
- K101333: Cryocare CS Surgical System (2010), 8 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: 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: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K012191
Methodology: https://510kreport.com/methodology