# K031350: 3TP Software Option

- Pathway: 510(k) (Traditional)
- Applicant: 3tp, LLC
- Decided: Jun 23, 2003 after 55 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913475 (1991). 7 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960265: Advantage Windows with Functool Option, GE Medical Systems (1996) Summary page 1.
- K011604: Prostate Spectroscopy and Imaging Exam (Prose) Software Option  for Mri, Ge Medical Systems, Inc. (2001)
- K971965: Philips Easyvision, Philips Medical Systems, Inc. (1998) Summary page 1.

## Most influential descendants
- K041286: Dynacad V1.0 (2004), 17 descendants of its own
- K081556: Cadstream, Version 5.0 (2009), 9 descendants of its own
- K092954: Cadstream Version 5 (2009), 8 descendants of its own
- K170195: QuantX (2017), 4 descendants of its own
- K210670: BU-CAD (2021), 3 descendants of its own

## Recalls of this device
- Dec 9, 2008 · Not classified · Z-0653-2009: Software modules not approved for this indication.

## Indications for use
The 3TP Software Option is intended to be used as a post processing software package designed to provide a reliable means for visualizing the presence and pattern of contrast induced enhancement on MR datasets. 3TP supports the evaluation of dynamic MR data gathered during the injection of a bolus of contrast media. The resulting time course information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images. In the hands of a trained physician the information provided by the 3TP Software Option could yield information that may assist in the interpretation of dynamic contrast enhanced studies.

Source page: https://510kreport.com/device/K031350
Methodology: https://510kreport.com/methodology