510(k) · Cleared
ClearedUnifi Workspace v1.0.0
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 Jul 11, 2019 as substantially equivalent to K140960 (Hologic, Inc., 2014) after a 115-day review. Its family tree reaches back 11 generations to 1996. 2 later devices descend from it.
- Decided
- Jul 11, 2019
- Review
- 115 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K954874 (1996). 45 ancestors in all, the oldest K885054 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 7 generations between
- 3 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 2 generations backK111694 ASTRACandelis, Inc. · 2011
- 1 generation backK140960 Picture Archiving and Communications SystemHologic, Inc. · 2014
- This deviceK190694 Unifi Workspace v1.0.0Hologic, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK220767 TeleScanBb Imaging · 2022
- Descendant · 2 generations on · 0 of its ownK233634 TeleScanBb Imaging · 2023
Show all 11 generations
- Root · 11 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 10 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 9 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 8 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 7 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 6 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 5 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 4 generations backK062163 MimviewerMimvista Corp. · 2006
- 3 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 2 generations backK111694 ASTRACandelis, Inc. · 2011
- 1 generation backK140960 Picture Archiving and Communications SystemHologic, Inc. · 2014
- This deviceK190694 Unifi Workspace v1.0.0Hologic, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −10 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −9 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −8 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −7 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −6 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −5 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −4 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −3 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −2 | K111694 | ASTRA | Candelis, Inc. | 2011 | — |
| −1 | K140960 | Picture Archiving and Communications System | Hologic, Inc. | 2014 | — |
| 0 (this device) | K190694 | Unifi Workspace v1.0.0 | Hologic, Inc. | 2019 | — |
| +1 | K220767 | TeleScan | Bb Imaging | 2022 | — |
| +2 | K233634 | TeleScan | Bb Imaging | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K140960 | Picture Archiving and Communications SystemSummary page 4…Class II Review Panel: Radiology Submitter/510(k) Holder: Hologic, Inc. Clearance: K140960 (cleared June 13, 2014) The legally marketed predicate device, Prima, has not been subject to a design-related recall. Identifi… | 2014 |
| † | K103385 | Securview DX Diagnostic Workstation | 2011 |
| † | K132316 | Multiview | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220767 | TeleScan | 2022 | 1 |
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 7 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 45 ancestors have a recall of any class.
- Of its descendants, K220767 (Bb Imaging, 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Unifi Workspace is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving mammography images as well as other medical images and data (e.g. US and MR). Images and data can be stored, communicated, and displayed within the system or across computer systems. Unifi Workspace provides various image processing and measurement tools to facilitate the interpretation of mammography X-ray…
Read the full statement (136 words)
Unifi Workspace is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving mammography images as well as other medical images and data (e.g. US and MR). Images and data can be stored, communicated, and displayed within the system or across computer systems. Unifi Workspace provides various image processing and measurement tools to facilitate the interpretation of mammography X-ray, breast tomosynthesis, and other multimodality DICOM medical images and enable diagnosis. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by the FDA.
Unifi Workspace is typically used by trained professionals, including radiologists, oncologists, surgeons, technologists, and clinicians and may provide information to be used for screening and diagnostic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190694 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190694: Unifi Workspace v1.0.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190694
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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