# K050376: Prowin

- Pathway: 510(k) (Traditional)
- Applicant: Medical Technologies International, Inc.
- Decided: Apr 7, 2005 after 52 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K021966 (2002). 3 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040686: M'ath STD, Intelligence IN Medical Technologies (2004) Summary page 1.
- K030223: Sonocalc, Sonometric Health, LLC (2003) Summary page 1.
- K021966: Q Lab Software, Advanced Technology Laboratories, Inc. (2002) Summary page 1.

## Most influential descendants
- K073156: Qplaque MR (2008), 21 descendants of its own
- K120636: Synapse 3D Cardiac Tools (2012), 19 descendants of its own
- K171222: Vitrea Software Toshiba Package; VSTP-001A (2017), 12 descendants of its own
- K173088: Vitrea Software Toshiba Package VSTP-001A (2018), 11 descendants of its own
- K183013: Vitrea Software Package, VSTP-001A (2018), 9 descendants of its own

## Indications for use
The Prowin TM software program is a Windows-based application used on a personal computer intended for viewing carotid ultrasound images and measuring arterial wall thickness. It is specifically indicated for the measurement of carotid artery far and near wall intima-media thickness (IMT) from images obtained from an ultrasound system. A physician may use this information in conjunction with other medical data in the assessment of a patient's cardiovascular risk.

Source page: https://510kreport.com/device/K050376
Methodology: https://510kreport.com/methodology