510(k) · Cleared
ClearedClimb Mammography Viewer Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Climb Medical Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 29, 2014 as substantially equivalent to K040468 (Cedara Software Corp., 2004) and 1 other predicate after a 98-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Aug 29, 2014
- Review
- 98 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K904519 (1991). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 5 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 4 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 3 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 2 generations backK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- 1 generation backK073272 Workstationone Breast Imaging WorkstationThree Palm Software, LLC · 2007
- This deviceK141364 Climb Mammography Viewer SoftwareClimb Medical Systems, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −5 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −4 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −3 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −2 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| −1 | K073272 | Workstationone Breast Imaging Workstation | Three Palm Software, LLC | 2007 | — |
| 0 (this device) | K141364 | Climb Mammography Viewer Software | Climb Medical Systems, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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 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? (2)
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 |
|---|---|---|---|
| * | K040468 | Cedara I-Softview and Cedara I-ReadmammoSummary page 4…l Controls Regulation Number 21 CFR 892.2050 Product Code LLZ: Radiological Image Processing System Predicate Devices Cedara I-SoftView / Cedara-I K040468 Cedara Software Corporation ReadMammo WorkstationOne™ Breast K0732… | 2004 |
| * | K073272 | Workstationone Breast Imaging WorkstationSummary page 4…s Cedara I-SoftView / Cedara-I K040468 Cedara Software Corporation ReadMammo WorkstationOne™ Breast K073272 Three Palm Software, LLC Imaging Workstation Description Climb Mammography Viewer So… | 2007 |
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 23 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 7 of the 18 ancestors have a recall of any class.
- 3 other devices also cite its predicate K040468.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Climb-Mammography Viewer is intended to be used by radiologists for the reading, manipulation and interpretation of DICOM digital breast images including mammography. Radiologists are able to select, display, manipulate, quantify, mark-up, print and exchange images.
Lossy compressed mammographic images must not be reviewed for primary image interpretations. Images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA for digital mammography. All images must conform to regulatory requirements. Image quality must conform to applicable quality guidance.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141364: Climb Mammography Viewer Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141364
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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