510(k) · Cleared
ClearedaPROMISE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exini Diagnostics AB · LLZ System, Image Processing, Radiological
Cleared on Jul 27, 2021 as substantially equivalent to K191262 (Exini Diagnostics AB, 2019) and 1 other predicate after a 60-day review. Its family tree reaches back 13 generations to 1991. 1 later device descends from it.
- Decided
- Jul 27, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K913770 (1991). 234 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations between
- 3 generations backK091001 Myrian 1.4Intrasense · 2009
- 2 generations backK113620 Myrian 1.11Intrasense · 2012
- 1 generation backK160334 Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas · 2016
- This deviceK211655 aPROMISEExini Diagnostics AB · 2021
- Descendant · cites it directly · 0 of its ownK220590 aPROMISE XExini Diagnostics AB · 2022
Show all 13 generations
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 11 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 10 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 9 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 8 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 7 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 6 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 5 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 4 generations backK071000 MyrianIntrasense · 2007
- 3 generations backK091001 Myrian 1.4Intrasense · 2009
- 2 generations backK113620 Myrian 1.11Intrasense · 2012
- 1 generation backK160334 Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas · 2016
- This deviceK211655 aPROMISEExini Diagnostics AB · 2021
Most influential descendants
Showing 1 of 1 · See all- K220590aPROMISE XExini Diagnostics AB · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −12 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −11 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −10 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −9 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −8 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −7 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −6 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −5 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −4 | K071000 | Myrian | Intrasense | 2007 | — |
| −3 | K091001 | Myrian 1.4 | Intrasense | 2009 | — |
| −2 | K113620 | Myrian 1.11 | Intrasense | 2012 | — |
| −1 | K160334 | Advanced Medical Imaging Software Suite (KSWVWR) | Keosys Sas | 2016 | — |
| 0 (this device) | K211655 | aPROMISE | Exini Diagnostics AB | 2021 | — |
| +1 | K220590 | aPROMISE X | Exini Diagnostics AB | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 14 | 0 |
| 1997 | 10 | 0 |
| 1998 | 16 | 0 |
| 1999 | 8 | 0 |
| 2000 | 16 | 0 |
| 2001 | 21 | 0 |
| 2002 | 17 | 0 |
| 2003 | 13 | 0 |
| 2004 | 18 | 0 |
| 2005 | 16 | 0 |
| 2006 | 10 | 0 |
| 2007 | 9 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K191262 | aBSISummary page 4…Processing System Regulatory Class: II Product Code: LLZ 3. PREDICATE DEVICE Predicate Device: Exini aBSI (K191262) 510(k) Summary Page 2 of 8 Secondar… | 2019 |
| * | K160334 | Advanced Medical Imaging Software Suite (KSWVWR)Summary page 5…k) Summary Page 2 of 8 Secondary Predicate Device: Keosys Medical Imaging Suite KSWVWR (K160334 Advanced Medical Imaging Software Suite) 4. DEVICE DESCRIPTION aPROMISE (automated PRO… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220590 | aPROMISE X | 2022 | 0 |
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 30 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 55 of the 234 ancestors have a recall of any class.
- Of its descendants, K220590 (Exini Diagnostics AB, 2022) has gone furthest, with 0 descendants 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. 2021, 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?
aPROMISE is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211655 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211655: aPROMISE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211655
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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