510(k) · Cleared
ClearedPrism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prism Clinical Imaging, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 9, 2009 as substantially equivalent to K061255 (Kyron Clinical Imaging, Inc., 2006) and 4 other predicates after a 157-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Mar 9, 2009
- Review
- 157 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K954678 (1996). 18 ancestors in all, the oldest K913475 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- 2 generations backK052467 Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc. · 2005
- 1 generation backK063031 Prism View, ModelKyron Clinical Imaging, Inc. · 2006
- This deviceK082964 Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View…Prism Clinical Imaging, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK122026 Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K122026Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| −2 | K052467 | Brain Viewrx Viewer, Version 1.0 | Kyron Clinical Imaging, Inc. | 2005 | — |
| −1 | K063031 | Prism View, Model | Kyron Clinical Imaging, Inc. | 2006 | — |
| 0 (this device) | K082964 | Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version… | Prism Clinical Imaging, Inc. | 2009 | — |
| +1 | K122026 | Prism Acquire Prism Process Prism View | Prism Clinical Imaging, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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 LNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K061255 | Brainacquirerx / Brainprocessrx Data Suite Version 1.0Summary page 1…ices Predicate System Manufacturer Reg. Data BrainAcquireRx TM, Prism Clinical Imaging, Inc. K061255 BrainProcessRx TM 10437 Innovation Dr., Suite 403 SE 6/13/2006 Wauwa… | 2006 |
| * | K052467 | Brain Viewrx Viewer, Version 1.0Summary page 1…uct code LNH (f/k/a Kyron Clinical Imaging) Class II BrainViewRx TM Prism Clinical Imaging, Inc. K052467, K063031 10437 Innovation Dr., Suite 403 SE 12/20/05,11/2/06 (a/k/a Prism View)… | 2005 |
| * | K063031 | Prism View, ModelSummary page 1…LNH (f/k/a Kyron Clinical Imaging) Class II BrainViewRx TM Prism Clinical Imaging, Inc. K052467, K063031 10437 Innovation Dr., Suite 403 SE 12/20/05,11/2/06 (a/k/a Prism View)… | 2006 |
| * | K010938 | Syngo Multimodality WorkstationSummary page 1…uct code LLZ (f/k/a Kyron Clinical Imaging) Class II Syngo ® Multimodality Siemens Medical Systems K010938 Workstation 186 Wood Ave. South SE 6/26/2001 Iseli… | 2001 |
| * | K960265 | Advantage Windows with Functool OptionSummary page 1…uct code LLZ Class II Advantage Windows with GE Medical Systems K960265 FuncTool Option 3000 N. Grandview Blvd SE 7/3/1996 Waukes… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122026 | Prism Acquire Prism Process Prism View | 2012 | 0 |
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?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K122026 (Prism Clinical Imaging, Inc., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
Prism Acquire® / Prism Process® software is used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism View® software provides visualization of anatomical with functional and physiologic imaging data sets. Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to…
Read the full statement (205 words)
Prism Acquire® / Prism Process® software is used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism View® software provides visualization of anatomical with functional and physiologic imaging data sets.
Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MR scanner are stored for use by Prism Process, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion.
Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion including diffusion tensor imaging (DTI).
The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082964: Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082964
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026