510(k) · Cleared
ClearedSecurview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003
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 Aug 18, 2006 as substantially equivalent to K041555 (Hologic, Inc., 2004) after a 25-day review. Its family tree reaches back 5 generations to 1991. 14 later devices descend from it.
- Decided
- Aug 18, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913770 (1991). 6 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 1 generation backK041555 Securview DX Softcopy WorkstationHologic, Inc. · 2004
- This deviceK062107 Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and…Hologic, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK103385 Securview DX Diagnostic WorkstationHologic, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 3 of its ownK140960 Picture Archiving and Communications SystemHologic, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK101842 ACIESKonica Minolta Medical & Graphic, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK190694 Unifi Workspace v1.0.0Hologic, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK133730 CO Pilot/Regius UniteaKonica Minolta, Inc. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K103385Securview DX Diagnostic WorkstationHologic, Inc. · 2011 · cites it directly9descendants
- K140960Picture Archiving and Communications SystemHologic, Inc. · 2014 · 2 generations on3descendants
- K101842ACIESKonica Minolta Medical & Graphic, Inc. · 2011 · cites it directly3descendants
- K190694Unifi Workspace v1.0.0Hologic, Inc. · 2019 · 3 generations on2descendants
- K133730CO Pilot/Regius UniteaKonica Minolta, Inc. · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −1 | K041555 | Securview DX Softcopy Workstation | Hologic, Inc. | 2004 | — |
| 0 (this device) | 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 |
| +2 | K140960 | Picture Archiving and Communications System | Hologic, Inc. | 2014 | — |
| +1 | K101842 | ACIES | Konica Minolta Medical & Graphic, Inc. | 2011 | — |
| +3 | K190694 | Unifi Workspace v1.0.0 | Hologic, Inc. | 2019 | — |
| +2 | K133730 | CO Pilot/Regius Unitea | Konica Minolta, Inc. | 2014 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K041555 | Securview DX Softcopy WorkstationSummary page 1…hone Number: (203) 731-8337 Fax Number: (203) 731-8440 Date Prepared: July 18, 2006 Predicate Device: K041555 SecurView DX, Hologic Inc. Device Description: The Hologic SecurView DX is mainly a software product. It is used for visualizati… | 2004 |
What descends from it? (14)
See all 142 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 15 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K103385 (Hologic, Inc., 2011) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K041555.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SecurView DX device 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 (101 words)
The Hologic SecurView DX device 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 SecurView 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/K062107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062107: Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062107
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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