# K011604: Prostate Spectroscopy and Imaging Exam (Prose) Software Option  for Mri

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Aug 22, 2001 after 90 days
- Product code: LNI (System, Nuclear Magnetic Resonance Spectroscopic)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930265 (1995). 1 ancestor in all.
21 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930265: Hydrogen Spectroscopy Option-Probe #M1040HS/HT, GE Medical Systems (1995) Summary page 2.

## Most influential descendants
- K031350: 3TP Software Option (2003), 19 descendants of its own
- K041286: Dynacad V1.0 (2004), 17 descendants of its own
- K050862: 3TP Workspace (2005), 10 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

## Indications for use
PROstate Spectroscopy and imaging Exam (PROSE) is an image guided, clinical imaging and spectroscopy package which acquires high resolution anatomical images and volume localized, water/lipid suppressed hydrogen spectra and/or multi-voxel spectroscopic images of the prostate gland using an endo-rectal coil with phased-array coils. PROSE option can be used in conjunction with a Magnetic Resonance Scanner to permit non-invasive acquisition of high resolution images and spectral information about relative concentrations of metabolites of prostate gland that can be interpreted by a trained physician, and yield information that may assist in diagnosis of prostate diseases.

Source page: https://510kreport.com/device/K011604
Methodology: https://510kreport.com/methodology