510(k) · Cleared
ClearedaBSI
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 Aug 5, 2019 as substantially equivalent to K122205 (Exini Diagnostics AB, 2012) after an 87-day review. Its family tree reaches back 8 generations to 1995. 2 later devices descend from it.
- Decided
- Aug 5, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K950279 (1995). 39 ancestors in all, the oldest K913475 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
- 7 generations backK964803 Univision Echocardiology SystemNetwork Concepts, Inc. · 1997
- 6 generations backK980060 EcholinkMpacs, LLC · 1998
- 5 generations backK992259 Echocardiography System Series 95000Camtronics, Ltd. · 1999
- 4 generations backK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · Recalled
- 3 generations backK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled
- 2 generations backK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
- 1 generation backK122205 EXINIExini Diagnostics AB · 2012
- This deviceK191262 aBSIExini Diagnostics AB · 2019
- Descendant · cites it directly · 1 of its ownK211655 aPROMISEExini Diagnostics AB · 2021
- Descendant · 2 generations on · 0 of its ownK220590 aPROMISE XExini Diagnostics AB · 2022
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 |
|---|---|---|---|---|---|
| −8 | K950279 | TOMTECP90 | Tomtec Imaging Systems, Inc. | 1995 | — |
| −7 | K964803 | Univision Echocardiology System | Network Concepts, Inc. | 1997 | — |
| −6 | K980060 | Echolink | Mpacs, LLC | 1998 | — |
| −5 | K992259 | Echocardiography System Series 95000 | Camtronics, Ltd. | 1999 | — |
| −4 | K041029 | Kinetdx | Siemens Medi Cal Solutions, Inc. | 2004 | 1 |
| −3 | K053133 | Syngo Dynamics, Version 5.0 | Siemens Medical Solutions USA, Inc. | 2005 | 2 |
| −2 | K111319 | Ibis Explorer and Markup Software | Medqia | 2011 | — |
| −1 | K122205 | EXINI | Exini Diagnostics AB | 2012 | — |
| 0 (this device) | K191262 | aBSI | Exini Diagnostics AB | 2019 | — |
| +1 | K211655 | aPROMISE | Exini Diagnostics AB | 2021 | — |
| +2 | K220590 | aPROMISE X | Exini Diagnostics AB | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K122205 | EXINISummary page 4…Radiological Regulatory Class: II Product Code: LLZ 3. PREDICATE DEVICE Predicate Device: EXINI (K122205) 510(k) Summary Page 2 of 6… | 2012 |
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 |
|---|---|---|---|
| K211655 | aPROMISE | 2021 | 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 24 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 39 ancestors have a recall of any class.
- Of its descendants, K211655 (Exini Diagnostics AB, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K122205.
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?
aBSI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images acquired using nuclear medicine (NM) imaging. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including lesion marking and quantitative analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191262: aBSI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191262
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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