510(k) · Cleared
ClearedCadstream Version 3.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Confirma, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jul 7, 2004 as substantially equivalent to K031779 (Confirma, Inc., 2003) and 3 other predicates after a 78-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jul 7, 2004
- Review
- 78 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K954678 (1996). 16 ancestors in all, the oldest K941223 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 4 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 3 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 2 generations backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- 1 generation backK031779 CadstreamConfirma, Inc. · 2003
- This deviceK041020 Cadstream Version 3.1Confirma, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −4 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −3 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −2 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| −1 | K031779 | Cadstream | Confirma, Inc. | 2003 | — |
| 0 (this device) | K041020 | Cadstream Version 3.1 | Confirma, Inc. | 2004 | — |
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 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 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? (4)
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 |
|---|---|---|---|
| * | K031779 | CadstreamSummary page 1…lent to the devices listed below: Model: CADstreamTM Version 2.0 Manufacturer: Confirma, Inc. 510 (k) Number: K031779 Model: MICS Intervention Aid and MICS Intervention Aid PC- software pac… | 2003 |
| * | K020289 | Mics Intervention Aid, Catalog # Mics-Mia and Mics-MiasSummary page 1…tware package used to support stereotactic localization device Manufacturer: Machnet BV 510 (k) Number: K020289 Model: Software to support Stereotactic Localization Device (SLD) inclu… | 2002 |
| * | K000832 | Sterotactic Localization Device (SLD)Summary page 1…ce (SLD) included in Phillips GYROSCAN NT system Manufacturer: Phillips Medical Systems 510 (k) Number: K000832 Model: Software to support MR Breast Biopsy Device included in Siemens… | 2000 |
| * | K010773 | Breast Biopsy Device/Magnetom SystemsSummary page 1…Biopsy Device included in Siemens MAGNETOM system Manufacturer: Siemens Medical Systems 510 (k) Number: K010773 4. Device Description: The CADstream device relies on the assumption that pixels having similar MR signal intensi… | 2001 |
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 8 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 16 ancestors have a recall of any class.
- 2 other devices also cite its predicate K031779.
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.
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?
CADstreamTM 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 performs other user-defined post-processing functions (image subtractions…
Read the full statement (236 words)
CADstreamTM 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 performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections).
CADstream also can be used to provide accurate and reproducible measurements of the longest diameters and volume of segmented tissues, including automated determination of volumes of interest (VOI), calculation of the longest diameter in X, Y and Z dimensions, the areas of VOI, the volume measurements of VOI (reported in cc), and 3D renderings of VOI.
The system includes an optional remote image viewer (CADalystTM), optimized for viewing breast MR studies processed by CADstream.
CADstreamTM includes software to support the use of breast interventional coils and MR stereotactic localization devices to perform breast interventional procedures (SureLocTM). 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.
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/K041020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041020: Cadstream Version 3.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041020
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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