510(k) · Cleared
ClearedProstate Spectroscopy and Imaging Exam (Prose) Software Option for Mri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · LNI System, Nuclear Magnetic Resonance Spectroscopic
Cleared on Aug 22, 2001 as substantially equivalent to K930265 (GE Medical Systems, 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995. 21 later devices descend from it.
- Decided
- Aug 22, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- LNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930265 (1995). 21 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK930265 Hydrogen Spectroscopy Option-Probe #M1040HS/HTGE Medical Systems · 1995
- This deviceK011604 Prostate Spectroscopy and Imaging Exam (Prose) Software Option for MriGe Medical Systems, Inc. · 2001
- Descendant · cites it directly · 19 of its ownK031350 3TP Software Option3tp, LLC · 2003 · Recalled
- Descendant · 2 generations on · 17 of its ownK041286 Dynacad V1.0Mri Devices Corp. · 2004
- Descendant · cites it directly · 10 of its ownK050862 3TP Workspace3tp, LLC · 2005 · Recalled
- Descendant · 2 generations on · 9 of its ownK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- Descendant · 3 generations on · 8 of its ownK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K0313503TP Software Option3tp, LLC · 2003 · cites it directly19descendants
- K041286Dynacad V1.0Mri Devices Corp. · 2004 · 2 generations on17descendants
- K0508623TP Workspace3tp, LLC · 2005 · cites it directly10descendants
- K081556Cadstream, Version 5.0Confirma, Inc. · 2009 · 2 generations on9descendants
- K092954Cadstream Version 5Confirma, Inc. · 2009 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930265 | Hydrogen Spectroscopy Option-Probe #M1040HS/HT | GE Medical Systems | 1995 | — |
| 0 (this device) | K011604 | Prostate Spectroscopy and Imaging Exam (Prose) Software Option for Mri | Ge Medical Systems, Inc. | 2001 | — |
| +1 | K031350 | 3TP Software Option | 3tp, LLC | 2003 | 1 |
| +2 | K041286 | Dynacad V1.0 | Mri Devices Corp. | 2004 | — |
| +1 | K050862 | 3TP Workspace | 3tp, LLC | 2005 | 1 |
| +2 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| +3 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 4 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930265 | Hydrogen Spectroscopy Option-Probe #M1040HS/HTSummary page 2…xam (PROSE) software option is substantially equivalent to existing scanning, processing and display features included with the GE Medical Systems PROBE software option (K930265). The PROBE software is modified to deliver improved spatial coverage through the PRESS volume and extend the use of the PROBE se… | 1995 |
What descends from it? (21)
See all 212 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LNI devicesLNI System, Nuclear Magnetic Resonance Spectroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNI
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LNI
Too few LNI 510(k)s in any year since 2007 to give a median.
Recalls per year · LNI
12in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LNI
1in 2025
MAUDE reports naming product code LNI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 4 | 1 |
| 2024 | 0 | — | 12 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011604 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011604: Prostate Spectroscopy and Imaging Exam (Prose) Software Option for Mri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011604
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026