510(k) · Cleared
ClearedSenolris
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · LLZ System, Image Processing, Radiological
Cleared on Aug 1, 2016 as substantially equivalent to K143361 (GE Healthcare, 2015) after a 119-day review. Its family tree reaches back 9 generations to 1984.
- Decided
- Aug 1, 2016
- Review
- 119 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K842308 (1984). 40 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 5 generations between
- 3 generations backK081630 Mammo WorkstationImage Diagnost International GmbH · 2008
- 2 generations backK123575 MammoworkstationImage Diagnost International GmbH · 2013
- 1 generation backK143361 Mammo WorkstationGE Healthcare · 2015
- This deviceK160937 SenolrisGE Healthcare · 2016
Show all 9 generations
- Root · 9 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 8 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 7 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 6 generations backK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
- 5 generations backK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
- 4 generations backK063628 Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 2006 · Recalled
- 3 generations backK081630 Mammo WorkstationImage Diagnost International GmbH · 2008
- 2 generations backK123575 MammoworkstationImage Diagnost International GmbH · 2013
- 1 generation backK143361 Mammo WorkstationGE Healthcare · 2015
- This deviceK160937 SenolrisGE Healthcare · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −8 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −7 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −6 | K023100 | Accusketch Cardiac Quantitative System W/ Advanced Analysis Components | General Electric Medical Systems Information Techn | 2002 | — |
| −5 | K042525 | Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital… | Ge Medical Systems Information Technologies | 2004 | 3 |
| −4 | K063628 | Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy | Ge Healthcare Integrated IT Solutions | 2006 | 3 |
| −3 | K081630 | Mammo Workstation | Image Diagnost International GmbH | 2008 | — |
| −2 | K123575 | Mammoworkstation | Image Diagnost International GmbH | 2013 | — |
| −1 | K143361 | Mammo Workstation | GE Healthcare | 2015 | — |
| 0 (this device) | K160937 | Senolris | GE Healthcare | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K143361 | Mammo WorkstationSummary page 4…Class II CFR 892.2050 System, Image Processing, Radiological, Product Code: LLZ Predicate Device(s): MammoWorkstation (K143361) Device Description: The SenoIris is a medical image review workstation software for diagnos… | 2015 |
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 32 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 14 of the 40 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
SenoIris is designed for diagnostic and non-diagnostic review in diagnostic and screening breast imaging environments through flexible and interactive manipulation of multi-modality, multi-vendor softcopy images. It provides image review, manipulation, analysis, Post-Processing and printing capabilities for FFDM, DBT, and CESM images. The software also supports the display of CAD, breast density assessments and other breast imaging data from various…
Read the full statement (209 words)
SenoIris is designed for diagnostic and non-diagnostic review in diagnostic and screening breast imaging environments through flexible and interactive manipulation of multi-modality, multi-vendor softcopy images.
It provides image review, manipulation, analysis, Post-Processing and printing capabilities for FFDM, DBT, and CESM images. The software also supports the display of CAD, breast density assessments and other breast imaging data from various modalities.
Image routing and compression, as well as centralized workflow steering, including double blind reading and integrated in-image reporting, are part of the solution to support the women’s healthcare professionals to enrich existing workflows for breast imaging needs.
Various specific and general interfaces exist to synchronize to other external software on the front- and back-end side. The software also provides functions to directly import data from and export them to mobile storage media or onto the local operating system.
Contraindications
Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless cleared for use in digital mammography.
Review monitors used for primary diagnostic interpretation of mammographic images must be cleared for use in digital mammography.
All images sent to or imported in the SenoIris must fulfill the regulatory requirements. Image quality must conform with applicable quality guidelines.
For Diagnose Mode, all modalities must be certified for soft-copy reading
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160937: Senolris.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160937
Report an extraction error
Are you the manufacturer?
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