510(k) · Cleared
ClearedTomo-Link
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · IZF System, X-Ray, Tomographic
Cleared on Dec 9, 1994 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 30 later devices descend from it.
- Decided
- Dec 9, 1994
- Review
- 59 days
- Class
- Class II
- Product code
- IZF
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 1 citing it directly.
- This deviceK944967 Tomo-LinkGE Medical Systems · 1994
- Descendant · cites it directly · 29 of its ownK051967 Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare · 2005 · Recalled
- Descendant · 2 generations on · 21 of its ownK132261 Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC · 2013 · Recalled
- Descendant · 3 generations on · 8 of its ownK183275 DR 800 with TomosynthesisAgfa N.V. · 2019 · Recalled
- Descendant · 3 generations on · 6 of its ownK143270 Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015
- Descendant · 2 generations on · 6 of its ownK121499 Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray…Fujifilm Medical System U.S.A., Inc. · 2012
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K051967Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare · 2005 · cites it directly29descendants
- K132261Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC · 2013 · 2 generations on21descendants
- K183275DR 800 with TomosynthesisAgfa N.V. · 2019 · 3 generations on8descendants
- K143270Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015 · 3 generations on6descendants
- K121499Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray SystemFujifilm Medical System U.S.A., Inc. · 2012 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944967 | Tomo-Link | GE Medical Systems | 1994 | — |
| +1 | K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | GE Healthcare | 2005 | 9 |
| +2 | K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis) | Ge Medical Systems, LLC | 2013 | 1 |
| +3 | K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019 | 3 |
| +3 | K143270 | Optima XR646 | Ge Hualun Medical Systems Co., Ltd. | 2015 | — |
| +2 | K121499 | Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZF? 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 IZF device
- #1 K250850 Nanox.ARC Xscore 15.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (30)
See all 301 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | 2005 | 29 |
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?
- Of its descendants, K051967 (GE Healthcare, 2005) has gone furthest, with 29 descendants of its own.
How does its category compare?
All IZF devicesIZF System, X-Ray, Tomographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZF
Too few IZF 510(k)s in any year since 2007 to give a median.
Recalls per year · IZF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZF
1in 2021
MAUDE reports naming product code IZF, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 24 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 1 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K944967 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944967: Tomo-Link.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944967
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026