510(k) · Cleared
ClearedBI-Rads Companion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Almen Laboratories, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 16, 2008 as substantially equivalent to K050846 (The Medipattern Corporation, 2005) after a 276-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- May 16, 2008
- Review
- 276 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913770 (1991). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 3 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 2 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 1 generation backK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- This deviceK072258 BI-Rads CompanionAlmen Laboratories, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −3 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −2 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −1 | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| 0 (this device) | K072258 | BI-Rads Companion | Almen Laboratories, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K050846 | B-Cad System, Version 1.0Summary page 1…BI-RADS Companion Common Name: Medical Image Processing System Classification: Class II, 21 CFR 892.2050 PACS Predicate Device: B-CAD System, Version 1.0 (K050846) Manufactured by: MEDIPATTERN CORPORATION 2300 Sheppard Avenue West Suite 20… | 2005 |
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 17 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 4 other devices also cite its predicate K050846.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
BI-RADS Companion TM ("BRC") is a computer-aided image viewing and report generating tool designed to assist radiologists in the analysis of ultrasound images of breast masses by making the ACR "BI-RADS Classification Form and Lexicon®" ("ABCFL") available in electronic format. The user can view any selected image from a case and segment the lesion from the background by applying a user selected threshold or outlining the lesion manually with a cursor.…
Read the full statement (186 words)
BI-RADS Companion TM ("BRC") is a computer-aided image viewing and report generating tool designed to assist radiologists in the analysis of ultrasound images of breast masses by making the ACR "BI-RADS Classification Form and Lexicon®" ("ABCFL") available in electronic format. The user can view any selected image from a case and segment the lesion from the background by applying a user selected threshold or outlining the lesion manually with a cursor.
The user can annotate, tag, measure, and record selected views. Under user control and review, the software electronically assembles reports from inputs selected by the user from the ultrasound ABCFL during the image interpretation process. The assembled report complies with the ABCFL for ultrasound. The output may be viewed and sent to electronic storage media, or standard film or paper printers or other document manipulation programs such as Adobe or Microsoft.
When used by a skilled radiologist, this device provides information that may be useful in image interpretation. Patient management decisions should not be based solely on forms generated by BRC.
The ultrasound images displayed by BRC must not be used for primary diagnostic interpretation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072258 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072258: BI-Rads Companion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072258
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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