510(k) · Cleared
ClearedMRCP+ version 2 (MRCP+ v2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perspectum · LLZ System, Image Processing, Radiological
Cleared on Mar 13, 2024 as substantially equivalent to K183133 (Perspectum Diagnostics, Ltd., 2019) after a 90-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Mar 13, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K954678 (1996). 17 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations between
- 3 generations backK082228 Planisight LinasysPathfinder Therapeutics, Inc. · 2008
- 2 generations backK131498 Iqqa-Liver Multimodality SoftwareEdda Technology, Inc. · 2013
- 1 generation backK183133 MRCP+ v1.0Perspectum Diagnostics, Ltd. · 2019
- This deviceK233930 MRCP+ version 2 (MRCP+ v2)Perspectum · 2024
Show all 9 generations
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 7 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 6 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 5 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 4 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 3 generations backK082228 Planisight LinasysPathfinder Therapeutics, Inc. · 2008
- 2 generations backK131498 Iqqa-Liver Multimodality SoftwareEdda Technology, Inc. · 2013
- 1 generation backK183133 MRCP+ v1.0Perspectum Diagnostics, Ltd. · 2019
- This deviceK233930 MRCP+ version 2 (MRCP+ v2)Perspectum · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −8 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −7 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −6 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −5 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −4 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −3 | K082228 | Planisight Linasys | Pathfinder Therapeutics, Inc. | 2008 | — |
| −2 | K131498 | Iqqa-Liver Multimodality Software | Edda Technology, Inc. | 2013 | — |
| −1 | K183133 | MRCP+ v1.0 | Perspectum Diagnostics, Ltd. | 2019 | — |
| 0 (this device) | K233930 | MRCP+ version 2 (MRCP+ v2) | Perspectum | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K183133 | MRCP+ v1.0Summary page 4…Subject Device Predicate Device 510(k) number K233930 K183133 Legal Manufacturer Perspectum Ltd. Perspectum Ltd. Owner/Owner Operator… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 8 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 17 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
MRCP+ v2 is indicated for use as a software-based image processing system for noninvasive, quantitative assessment of biliary system structures. MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable the measurement of bile duct widths and quantification of strictures and dilatations. MRCP+ v2 includes tools for interactive segmentation and labelling of the biliary system, including the gallbladder. MRCP+ v2 provides metrics…
Read the full statement (108 words)
MRCP+ v2 is indicated for use as a software-based image processing system for noninvasive,
quantitative assessment of biliary system structures.
MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable the
measurement of bile duct widths and quantification of strictures and dilatations. MRCP+ v2 includes
tools for interactive segmentation and labelling of the biliary system, including the gallbladder.
MRCP+ v2 provides metrics for interpretation by trained physicians to assist in the assessment of
the biliary system. These metrics support physicians in the visualization, evaluation and reporting of
hepatobiliary structures.
MRCP+ v2 is designed to utilize DICOM-compliant MRCP datasets acquired on supported MR
scanners using supported MRCP acquisition protocols.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233930: MRCP+ version 2 (MRCP+ v2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233930
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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