510(k) · Cleared
ClearedMammo Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Image Diagnost International GmbH · LLZ System, Image Processing, Radiological
Cleared on Jul 29, 2008 as substantially equivalent to K040468 (Cedara Software Corp., 2004) and 2 other predicates after a 48-day review. Its family tree reaches back 6 generations to 1984. 4 later devices descend from it.
- Decided
- Jul 29, 2008
- Review
- 48 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K842308 (1984). 29 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 5 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 4 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 3 generations backK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
- 2 generations backK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
- 1 generation backK063628 Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 2006 · Recalled
- This deviceK081630 Mammo WorkstationImage Diagnost International GmbH · 2008
- Descendant · cites it directly · 2 of its ownK123575 MammoworkstationImage Diagnost International GmbH · 2013
- Descendant · 2 generations on · 1 of its ownK143361 Mammo WorkstationGE Healthcare · 2015
- Descendant · 3 generations on · 0 of its ownK160937 SenolrisGE Healthcare · 2016
- Descendant · cites it directly · 0 of its ownK132188 Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K123575MammoworkstationImage Diagnost International GmbH · 2013 · cites it directly2descendants
- K143361Mammo WorkstationGE Healthcare · 2015 · 2 generations on1descendant
- K160937SenolrisGE Healthcare · 2016 · 3 generations on0descendants
- K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −5 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −4 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −3 | K023100 | Accusketch Cardiac Quantitative System W/ Advanced Analysis Components | General Electric Medical Systems Information Techn | 2002 | — |
| −2 | K042525 | Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital… | Ge Medical Systems Information Technologies | 2004 | 3 |
| −1 | K063628 | Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy | Ge Healthcare Integrated IT Solutions | 2006 | 3 |
| 0 (this device) | K081630 | Mammo Workstation | Image Diagnost International GmbH | 2008 | — |
| +1 | K123575 | Mammoworkstation | Image Diagnost International GmbH | 2013 | — |
| +2 | K143361 | Mammo Workstation | GE Healthcare | 2015 | — |
| +3 | K160937 | Senolris | GE Healthcare | 2016 | — |
| +1 | K132188 | Mammography Viewer SMV658 | Fujifilm Medical System U.S.A., Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K040468 | Cedara I-Softview and Cedara I-ReadmammoSummary page 1…Class 1ICFR 892.2050 System, Image Processing, Radiological, LLZ Predicate Devices: 1. Cedara Software Corp. 510(k) Number: K040468 Device: Cedara 1-ReadMammo 2. Sectra Ilmtec AB… | 2004 |
| * | K063093 | Sectra Workstation, Version 11.1Summary page 1…68 Device: Cedara 1-ReadMammo 2. Sectra Ilmtec AB 510(k) Number: K063093 Device: Sectra Workstation IDS5/mx.net 3. GE Healthcare I… | 2006 |
| * | K063628 | Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopySummary page 1…vice: Sectra Workstation IDS5/mx.net 3. GE Healthcare Integrated IT Solutions 510(k) Number: K063628 Device: Centricity Radiology RA600 Device Description: The MammoWorkstation is a… | 2006 |
What descends from it? (4)
2 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 24 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 11 of the 29 ancestors have a recall of any class.
- Of its descendants, K123575 (Image Diagnost International GmbH, 2013) has gone furthest, with 2 descendants of its own.
- 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. 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?
MammoWorkstation is designed to assist radiologists in conducting primary diagnostic review for diagnostic and screening mammography through flexible and interactive manipulation of multi-modality softcopy images. It provides image review, manipulation, analysis, post-processing and printing capabilities that support image management display needs in the medical environment. MammoWorkstation is designed to give easy and economic access to and display of…
Read the full statement (182 words)
MammoWorkstation is designed to assist radiologists in conducting primary diagnostic review for diagnostic and screening mammography through flexible and interactive manipulation of multi-modality softcopy images.
It provides image review, manipulation, analysis, post-processing and printing capabilities that support image management display needs in the medical environment.
MammoWorkstation is designed to give easy and economic access to and display of multi-modality softcopy images, structured reports, and CAD results through interfaces to various image storage devices using DICOM or similar interface standards. It supports creation of structured reports according to the DICOM breast imaging report templates.
MammoWorkstation supports teleradiology and teleconferencing providing access to multi-modality softcopy images and structured reports in multiple locations within and outside the hospital.
Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography.
Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.
All images sent to or imported in the Mammoworkstation must conform to regulatory requirements. Image quality must conform with applicable quality guidelines. All modalities must be certified for soft-copy reading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081630 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081630: Mammo Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081630
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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