510(k) · Cleared
Recalled · 2012Securview DX Diagnostic Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 2, 2011 as substantially equivalent to K062107 (Hologic, Inc., 2006) after a 76-day review. Its family tree reaches back 6 generations to 1991. 9 later devices descend from it. It has been recalled once.
- Decided
- Feb 2, 2011
- Review
- 76 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913770 (1991). 7 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- 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 backK041555 Securview DX Softcopy WorkstationHologic, Inc. · 2004
- 1 generation backK062107 Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and…Hologic, Inc. · 2006
- This deviceK103385 Securview DX Diagnostic WorkstationHologic, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK140960 Picture Archiving and Communications SystemHologic, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK190694 Unifi Workspace v1.0.0Hologic, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK123575 MammoworkstationImage Diagnost International GmbH · 2013
- Descendant · 3 generations on · 1 of its ownK220767 TeleScanBb Imaging · 2022
- Descendant · 2 generations on · 1 of its ownK143361 Mammo WorkstationGE Healthcare · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K140960Picture Archiving and Communications SystemHologic, Inc. · 2014 · cites it directly3descendants
- K190694Unifi Workspace v1.0.0Hologic, Inc. · 2019 · 2 generations on2descendants
- K123575MammoworkstationImage Diagnost International GmbH · 2013 · cites it directly2descendants
- K220767TeleScanBb Imaging · 2022 · 3 generations on1descendant
- K143361Mammo WorkstationGE Healthcare · 2015 · 2 generations on1descendant
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 | K041555 | Securview DX Softcopy Workstation | Hologic, Inc. | 2004 | — |
| −1 | K062107 | Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003 | Hologic, Inc. | 2006 | — |
| 0 (this device) | K103385 | Securview DX Diagnostic Workstation | Hologic, Inc. | 2011 | — |
| +1 | K140960 | Picture Archiving and Communications System | Hologic, Inc. | 2014 | — |
| +2 | K190694 | Unifi Workspace v1.0.0 | Hologic, Inc. | 2019 | — |
| +1 | K123575 | Mammoworkstation | Image Diagnost International GmbH | 2013 | — |
| +3 | K220767 | TeleScan | Bb Imaging | 2022 | — |
| +2 | K143361 | Mammo Workstation | GE Healthcare | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K062107 | Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003Summary page 1…is Telephone Number: (203) 731-8337 Fax Number: (203) 731-8440 Date Prepared: January 5, 2011 Predicate Device: K062107 Securiew DX, Hologic Inc. Predicate Device Description: The Hologic Securiew DX is mainly asoftware product. It is… | 2006 |
| † | K062059 | Aie Region of Interest Image Enhancement | 2006 |
What descends from it? (9)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2012 | Not classified | Z-1370-2012 | Software design | SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K140960 (Hologic, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K062107.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Hologic Securiew DX is intended for selection, display, manipulation, filming and media interchange of multi-modality images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards. The device used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed…
Read the full statement (100 words)
The Hologic Securiew DX is intended for selection, display, manipulation, filming and media interchange of multi-modality images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards.
The device used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image.
The Securiew DX is typically used by trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103385: Securview DX Diagnostic Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103385
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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