# K030191: Terason Model 2000/Bas Portable Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: Jan 29, 2003 after 8 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: 3 generations back to K926514 (1993). 10 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012191: Teratech Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes, Teratech Corp. (2001) Summary page 7.
- K994373: Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer (MTP7-4), Atl Ultrasound, Inc. (2000) Summary page 1.
- K993624: Site-Rite 3 Ultrasound System, Dymax Corp (1999) Summary page 1.

## Most influential descendants
- 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
- K141110: Cryocare CS Surgical System (2015), 7 descendants of its own

## Indications for use
The TERASON Model 2000/BAS Portable Ultrasound Systems are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission.

Source page: https://510kreport.com/device/K030191
Methodology: https://510kreport.com/methodology