# K040840: Teratech Model 10V5 Smart Probe

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: Apr 14, 2004 after 13 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 5 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 10V4 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
- K072266: Acuson P50 Diagnostic Ultrasound System (2007), 1 descendant of its own
- K083114: Acuson P50 Ultrasound System (2009), 0 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/K040840
Methodology: https://510kreport.com/methodology