510(k) · Cleared
ClearedCadstream
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Confirma, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 6, 2003 as substantially equivalent to K002519 (Vital Images, Inc., 2000) and 4 other predicates after a 57-day review. Its family tree reaches back 4 generations to 1996. 19 later devices descend from it.
- Decided
- Aug 6, 2003
- Review
- 57 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K954678 (1996). 11 ancestors in all, the oldest K941223 (1994). 19 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 3 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 2 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 1 generation backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- This deviceK031779 CadstreamConfirma, Inc. · 2003
- Descendant · cites it directly · 17 of its ownK041286 Dynacad V1.0Mri Devices Corp. · 2004
- Descendant · cites it directly · 9 of its ownK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK170195 QuantXQuantitative Insights, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK210670 BU-CADTaihao Medical, Inc. · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K041286Dynacad V1.0Mri Devices Corp. · 2004 · cites it directly17descendants
- K081556Cadstream, Version 5.0Confirma, Inc. · 2009 · cites it directly9descendants
- K092954Cadstream Version 5Confirma, Inc. · 2009 · 2 generations on8descendants
- K170195QuantXQuantitative Insights, Inc. · 2017 · 2 generations on4descendants
- K210670BU-CADTaihao Medical, Inc. · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −3 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −2 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −1 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| 0 (this device) | K031779 | Cadstream | Confirma, Inc. | 2003 | — |
| +1 | K041286 | Dynacad V1.0 | Mri Devices Corp. | 2004 | — |
| +1 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| +2 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| +2 | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| +3 | K210670 | BU-CAD | Taihao Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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? (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 |
|---|---|---|---|
| * | K002519 | Vitrea 2, Version 2.1 | 2000 |
| * | K992654 | Plug 'N View 3D, Version 1.0Summary page 1…e Processing Software Classification Name: 90 LLZ Substantially Equivalent To: Vitrea 2: KO02519 Voxar Plug n' View 3D: K992654 Vital Images Voxar Limited 3300 Fernbrook Lane North Bonnington Bond,… | 1999 |
| * | K961023 | Aidp (Accuimage Image Display Processor)Summary page 1…Anderson Place Plymouth, MN 55447-5341 Edinburgh, UK EH6 5 NP AccuImage h a g c Display Software: Fusion 7D: KO20546 K961023 Mirada Solutions Ltd Accuhage, Inc. Mill Street 16303… | 1996 |
| * | K020546 | Fusion 7D | 2002 |
| * | K984221 | Functional Mri Package for Magetetom Vision MRSummary page 1…Mill Street 16303 Panormaic Way Oxford, UK O X 2 OJX San Leandro, CA 94578-1 116 Siemens BOLD MRI: K984221 Siemens Corp 186 Wood Avenue, South Iselin, NJ 08830 KO31 779 Confirma, Inc. Jul… | 1999 |
What descends from it? (19)
See all 193 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?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K041286 (Mri Devices Corp., 2004) has gone furthest, with 17 descendants of its own.
- 12 other devices also cite its predicate K002519.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
CADstream is a Computer Aided Detection (CAD) system intended for use in analyzing magnetic resonance imaging (MRI) studies. CADstream automatically registers serial patient image acquisitions to minimize the impact of patient motion. segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity…
Read the full statement (110 words)
CADstream is a Computer Aided Detection (CAD) system intended for use in analyzing magnetic resonance imaging (MRI) studies. CADstream automatically registers serial patient image acquisitions to minimize the impact of patient motion. segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections).
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. CADstream can also be used to provide accurate and reproducible measurements of the longest diameters and volume of segmented tissues. Patient management decisions should not be made based solely on the results of CADstrearn analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031779: Cadstream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031779
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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