510(k) · Cleared
ClearedAki Compacs Data Compresion Module for Diagnostic Images
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.L.I. Technologies, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 27, 1996 as substantially equivalent to K955092 (Cemax-Icon, Inc., 1996) after a 78-day review. Its family tree reaches back 1 generation to 1996. 31 later devices descend from it.
- Decided
- Nov 27, 1996
- Review
- 78 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955092 (1996). 31 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK955092 Accurad Image Management System, Autorad, Regustration Station…Cemax-Icon, Inc. · 1996
- This deviceK963610 Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc. · 1996
- Descendant · cites it directly · 16 of its ownK023772 Kinetdx Picture Archiving and Communications SystemAcuson Corp. · 2002 · Recalled
- Descendant · 2 generations on · 13 of its ownK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 7 of its ownK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · cites it directly · 7 of its ownK982563 Ultrapro Model 98Ramsoft, Inc. · 1998
- Descendant · 4 generations on · 6 of its ownK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K023772Kinetdx Picture Archiving and Communications SystemAcuson Corp. · 2002 · cites it directly16descendants
- K041029KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · 2 generations on13descendants
- K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · 3 generations on7descendants
- K982563Ultrapro Model 98Ramsoft, Inc. · 1998 · cites it directly7descendants
- K111319Ibis Explorer and Markup SoftwareMedqia · 2011 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive… | Cemax-Icon, Inc. | 1996 | — |
| 0 (this device) | K963610 | Aki Compacs Data Compresion Module for Diagnostic Images | A.L.I. Technologies, Inc. | 1996 | — |
| +1 | K023772 | Kinetdx Picture Archiving and Communications System | Acuson Corp. | 2002 | 5 |
| +2 | K041029 | Kinetdx | Siemens Medi Cal Solutions, Inc. | 2004 | 1 |
| +3 | K053133 | Syngo Dynamics, Version 5.0 | Siemens Medical Solutions USA, Inc. | 2005 | 2 |
| +1 | K982563 | Ultrapro Model 98 | Ramsoft, Inc. | 1998 | — |
| +4 | K111319 | Ibis Explorer and Markup Software | Medqia | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive Server, Print…Summary page 1…vices is Picture Archiving and Communications Systems. 8.3 Devices to which Substantial Equivalence is being Claimed CEMAX-ICON Archive Manager 2.0 and Autorad modules (K955092). 84 Device Description 8.4.1 Function The ALl comPACS Data Compression Module for Diagnostic Images is an accessory to the AL… | 1996 |
What descends from it? (31)
See all 314 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?
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 ALI comPACS Data Compression Module for Diagnostic images is an accessory to the ALI UtraPACS (K925965/A) Picture Archiving and Communication System. Through the use of JPEG and Motion JPEG lossy compression, ALI comPACS is intended to provide: 1. significant reductions in the amount of electronic storage space for digitized diagnostic still images and digitized video of diagnostic images while maintaining medically acceptable diagnostic quality of…
Read the full statement (103 words)
The ALI comPACS Data Compression Module for Diagnostic images is an accessory to the ALI UtraPACS (K925965/A) Picture Archiving and Communication System. Through the use of JPEG and Motion JPEG lossy compression, ALI comPACS is intended to provide:
1. significant reductions in the amount of electronic storage space for digitized diagnostic still images and digitized video of diagnostic images while maintaining medically acceptable diagnostic quality of the images; and
2. significant reductions in the amount of time to transmit digitized diagnostic still images and digitized video of diagnostic images from storage to viewing sites, while maintaining medically acceptable diagnostic quality of the images.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963610 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963610: Aki Compacs Data Compresion Module for Diagnostic Images.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963610
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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