510(k) · Cleared
ClearedCadstream Version 4.0
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 Jan 6, 2005 as substantially equivalent to K033400 (Ge Medical Systems W-400, 2003) and 2 other predicates after a 45-day review. Its family tree reaches back 4 generations to 1991. 263 later devices descend from it.
- Decided
- Jan 6, 2005
- Review
- 45 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K913770 (1991). 7 ancestors in all. 263 later devices descend from it, 9 citing it directly.
- Root · 4 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 3 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 2 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 1 generation backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- This deviceK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- Descendant · cites it directly · 123 of its ownK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- Descendant · 2 generations on · 101 of its ownK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 3 generations on · 99 of its ownK143089 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 3 generations on · 98 of its ownK143264 H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 4 generations on · 97 of its ownK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
Showing 5 of 263 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 263 · See all- K050846B-Cad System, Version 1.0The Medipattern Corporation · 2005 · cites it directly123descendants
- K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 2 generations on101descendants
- K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 3 generations on99descendants
- K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 3 generations on98descendants
- K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 4 generations on97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −3 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −2 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −1 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| 0 (this device) | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| +1 | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| +2 | K141620 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +3 | K143089 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +3 | K143264 | H60 V2.00 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +4 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 8 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 13 | 0 |
| 2017 | 19 | 0 |
| 2018 | 20 | 0 |
| 2019 | 19 | 0 |
| 2020 | 16 | 0 |
| 2021 | 27 | 0 |
| 2022 | 22 | 0 |
| 2023 | 17 | 0 |
| 2024 | 21 | 0 |
| 2025 | 24 | 0 |
| 2026 | 15 | 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? (3)
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 |
|---|---|---|---|
| * | K033400 | Seno AdvantageSummary page 1…d below: Model: Seno Advantage Manufacturer: GE Medical Systems 5 10 (k) Number: K033400 Model: Sectra IIDS5 Radiology Workstation Manufacturer: Sectra-… | 2003 |
| * | K033712 | Modification to Sectra IDS5 Radiology Workstation - Version 10.1Summary page 1…Model: Sectra IIDS5 Radiology Workstation Manufacturer: Sectra-Lmtec Ab 5 10 (k) Number: K0337 12, K040376 Original 510(k) PreMarket Notification 15 Confirma, Inc.… | 2003 |
| * | K040376 | Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D PackageSummary page 1…: Sectra IIDS5 Radiology Workstation Manufacturer: Sectra-Lmtec Ab 5 10 (k) Number: K0337 12, K040376 Original 510(k) PreMarket Notification 15 Confirma, Inc.… | 2004 |
What descends from it? (263)
See all 2639 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050846 | B-Cad System, Version 1.0 | 2005 | 123 |
| K070244 | AEGIS | 2007 | 89 |
| K052305 | Mri Soft Tissue Motion Correction Software VA10A | 2005 | 34 |
| K080196 | Z3D Contrast Acuity | 2008 | 10 |
| K081556 | Cadstream, Version 5.0 | 2009 | 9 |
| K211039 | BIT-Motion | 2021 | 0 |
| K090038 | Syngo Brevis | 2009 | 0 |
| K090223 | Icad Breast Interventional Planning Software, Model D70024 | 2009 | 0 |
| K052023 | Cadimas Version 1.0 | 2005 | 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 14 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K050846 (The Medipattern Corporation, 2005) has gone furthest, with 123 descendants of its own.
- 8 other devices also cite its predicate K033400.
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 (in 2D or 3D) to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps, referred to as angiogenesis maps), and provides quantitative measurements of morphological features of the…
Read the full statement (336 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 (in 2D or 3D) to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps, referred to as angiogenesis maps), and provides quantitative measurements of morphological features of the segmented tissues. CADstream performs other user-defined post-processing functions (image subtractions, multiplanar and oblique reformats, maximum intensity projections, image averaging, removal of cardiac artifact).
CADstream also can be used to provide accurate and reproducible measurements of the segmented tissues volumes (volumes of interest (VOI)). These measurements include longest diameter, longest in-plane diameters, volume measurement (reported in cc), ratio of breast volume to V0l, distance of VOl to anatomical landmarks, and 3D renderings of the VOl.
The system includes an optional remote image viewer (CADalystTM), optimized for viewing breast MR studies processed by CADstream. CADalyst also displays and telecommunicates images from a number of other medical modalities, including ultrasound and digitized mammographic images, processed data from FDA-cleared third party image processing systems, and FDA-approved systems for computer-aided detection and advanced image processing. The ultrasound and digitized mammographic images displayed on the CADalyst remote image viewer must not be used for primary diagnostic interpretation.
CADstreamTM includes software to support the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures (SureLoc TM). Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion.
CADstream also includes the option to add annotations based on the American College of Radiology's Breast Imaging Reporting and Data System (B1-RADS®) Breast Imaging Atlas.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CADstream analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043216 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043216: Cadstream Version 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043216
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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