510(k) · Cleared
ClearedRegistration and Fusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare Corporation · LLZ System, Image Processing, Radiological
Cleared on Jan 17, 2008 as substantially equivalent to K043441 (Segami Corporation, 2005) after a 14-day review. Its family tree reaches back 1 generation to 2005. 5 later devices descend from it.
- Decided
- Jan 17, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043441 (2005). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK043441 Mirage, Release 5.5Segami Corporation · 2005
- This deviceK080013 Registration and FusionAgfa Healthcare Corporation · 2008
- Descendant · cites it directly · 4 of its ownK111638 Impax Volume ViewingAgfa Healthcare N.V. · 2011
- Descendant · cites it directly · 3 of its ownK133135 Impax Volume Viewing 3.0Agfa Healthcare N.V. · 2014
- Descendant · 2 generations on · 1 of its ownK142316 IMPAX AgilityAgfa Healthcare N.V. · 2015
- Descendant · 2 generations on · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
- Descendant · 2 generations on · 0 of its ownK161061 IMPAX Volume Viewing 4.0Agfa Healthcare N.V. · 2016
Most influential descendants
Showing 5 of 5 · See all- K111638Impax Volume ViewingAgfa Healthcare N.V. · 2011 · cites it directly4descendants
- K133135Impax Volume Viewing 3.0Agfa Healthcare N.V. · 2014 · cites it directly3descendants
- K142316IMPAX AgilityAgfa Healthcare N.V. · 2015 · 2 generations on1descendant
- K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025 · 2 generations on0descendants
- K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043441 | Mirage, Release 5.5 | Segami Corporation | 2005 | — |
| 0 (this device) | K080013 | Registration and Fusion | Agfa Healthcare Corporation | 2008 | — |
| +1 | K111638 | Impax Volume Viewing | Agfa Healthcare N.V. | 2011 | — |
| +1 | K133135 | Impax Volume Viewing 3.0 | Agfa Healthcare N.V. | 2014 | — |
| +2 | K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015 | — |
| +2 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
| +2 | K161061 | IMPAX Volume Viewing 4.0 | Agfa Healthcare N.V. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K043441 | Mirage, Release 5.5Summary page 1…xt. 3297 Facsimile: (519) 746-3745 A. LEGALLY MARKETED PREDICATE DEVICES This is a 510(k) for Agfa's Registration and Fusion software. The predicate device, Mirage 5.5 (K043441), manufactured by Segami Corporation. The new device is similar in indications and intended use as the predicate device. B. DEVI… | 2005 |
What descends from it? (5)
2 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. 2008, 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?
Registration and Fusion (Basic and Extended) is indicated for the simultaneous visualization of multiple medical images of the same patient. The application can assist the user in visually matching and comparing anatomical studies taken at different times or acquired via different imaging modalities (Basic: CT-CT, CT-MR, MR-MR, Extended: CT-PET, MR-PET) as well as assist in making measurements. It is primarily used in the fields of diagnostic radiology, neurology and oncology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080013 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080013: Registration and Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080013
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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