510(k) · Cleared
ClearedAetmed Image Processing Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aetmed, S.P.A. · LLZ System, Image Processing, Radiological
Cleared on Sep 21, 2001 as substantially equivalent to K000474 (Electromed Intl., Ltd., 2000) and 2 other predicates after a 78-day review. Its family tree reaches back 3 generations to 1990. 64 later devices descend from it.
- Decided
- Sep 21, 2001
- Review
- 78 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K896095 (1990). 6 ancestors in all. 64 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 2 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 1 generation backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- This deviceK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- Descendant · cites it directly · 61 of its ownK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- Descendant · 2 generations on · 50 of its ownK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- Descendant · 2 generations on · 32 of its ownK090439 FORUMCarl Zeiss Meditec, Inc. · 2009
- Descendant · 2 generations on · 29 of its ownK093313 SynergyTopcon Medical Systems, Inc. · 2009
- Descendant · 3 generations on · 25 of its ownK122938 Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · Recalled
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K013694Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002 · cites it directly61descendants
- K082364Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…Topcon Corp. · 2008 · 2 generations on50descendants
- K090439FORUMCarl Zeiss Meditec, Inc. · 2009 · 2 generations on32descendants
- K093313SynergyTopcon Medical Systems, Inc. · 2009 · 2 generations on29descendants
- K122938Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −2 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −1 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| 0 (this device) | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| +1 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| +2 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| +2 | K090439 | FORUM | Carl Zeiss Meditec, Inc. | 2009 | — |
| +2 | K093313 | Synergy | Topcon Medical Systems, Inc. | 2009 | — |
| +3 | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist Match | Carl Zeiss Meditec, AG | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2017 | 8 | 0 |
| 2018 | 7 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K000474 | View NTSummary page 1…re Common Name: Image Processing Software Classification Name(s): System, Image Processing Classification Number: LLZ 807.92(a)(3) Predicate Device(s) Electromed View NT K000474 Applicare Radworks Medical Imaging K982862 Software with Quality Control Module Cemax-Icon Accurad Image management System; K9550… | 2000 |
| * | K982862 | Radworks Medical Imaging Software with Quality Control ModuleSummary page 1…lassification Name(s): System, Image Processing Classification Number: LLZ 807.92(a)(3) Predicate Device(s) Electromed View NT K000474 Applicare Radworks Medical Imaging K982862 Software with Quality Control Module Cemax-Icon Accurad Image management System; K955092 AutoRad Regustr Additional Substantial… | 1998 |
| * | K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive Server, Print…Summary page 1…redicate Device(s) Electromed View NT K000474 Applicare Radworks Medical Imaging K982862 Software with Quality Control Module Cemax-Icon Accurad Image management System; K955092 AutoRad Regustr Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison T… | 1996 |
| * | — | AutoRad Regustr Named without a submission number |
What descends from it? (64)
See all 642 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K013694 (Nidek, Inc., 2002) has gone furthest, with 61 descendants of its own.
- 1 other device also cites its predicate K000474.
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 AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies.
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/K012093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012093: Aetmed Image Processing Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012093
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026