510(k) · Cleared
ClearedMedws Software (Variants Medview, Meddiag, Medmammo)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medecom Sarl · LLZ System, Image Processing, Radiological
Cleared on May 23, 2014 as substantially equivalent to K103385 (Hologic, Inc., 2011) after a 268-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- May 23, 2014
- Review
- 268 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913770 (1991). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 4 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 3 generations backK041555 Securview DX Softcopy WorkstationHologic, Inc. · 2004
- 2 generations backK062107 Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and…Hologic, Inc. · 2006
- 1 generation backK103385 Securview DX Diagnostic WorkstationHologic, Inc. · 2011 · Recalled
- This deviceK132684 Medws Software (Variants Medview, Meddiag, Medmammo)Medecom Sarl · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −5 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −4 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −3 | K041555 | Securview DX Softcopy Workstation | Hologic, Inc. | 2004 | — |
| −2 | K062107 | Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003 | Hologic, Inc. | 2006 | — |
| −1 | K103385 | Securview DX Diagnostic Workstation | Hologic, Inc. | 2011 | 1 |
| 0 (this device) | K132684 | Medws Software (Variants Medview, Meddiag, Medmammo) | Medecom Sarl | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (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 |
|---|---|---|---|
| * | K103385 | Securview DX Diagnostic WorkstationSummary page 1…16 100 CHATEAUBERNARD FRANCE Phone: +33 545 321 884 Fax: +33 963 294 139 Email: [email protected] Predicate Device (21 CFR 807.92(a)(3)): 510k number: K103385 Regulation number: 892.2050 Device name: SecurView DX Applicant: Hologic, Inc, 35 Crosby Drive, Bedford, MA 01730, USA Classif… | 2011 |
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 5 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K103385.
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?
The MEDWS Software (MEDVIEWS, MEDDIAG, MEDMAMMO) is intended for selection, display, manipulation and media interchange of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing device using DICOM or similar interface standards. Lossy compressed mammographic image are not intended for diagnostic review. Mammographic images should only be viewed with a monitor cleared by FDA…
Read the full statement (104 words)
The MEDWS Software (MEDVIEWS, MEDDIAG, MEDMAMMO) is intended for selection, display, manipulation and media interchange of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing device using DICOM or similar interface standards.
Lossy compressed mammographic image are not intended for diagnostic review. Mammographic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM for presentation images must be used.
The MEDWS Software (MEDVIEWS, MEDDIAG, MEDMVAMMO) is typically used by trained professionals including but not limited to physicians, radiologists, nurses, medical technicians and assistants.
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/K132684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132684: Medws Software (Variants Medview, Meddiag, Medmammo).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132684
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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