510(k) · Cleared
ClearedKodak Cardiology Digital Archive & Review System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jamieson Film Co. · LLZ System, Image Processing, Radiological
Cleared on Mar 27, 1996 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 145 later devices descend from it.
- Decided
- Mar 27, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
145 later devices descend from it, 2 citing it directly.
- This deviceK960043 Kodak Cardiology Digital Archive & Review SystemJamieson Film Co. · 1996
- Descendant · cites it directly · 143 of its ownK972229 Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 1997
- Descendant · 2 generations on · 142 of its ownK994210 Inturis SuitePhilips Medical Systems, Inc. · 2000
- Descendant · 3 generations on · 129 of its ownK022788 Philips Harmony Release 1Philips Medical Systems North America Co. · 2002 · Recalled
- Descendant · 4 generations on · 128 of its ownK061995 XceleraPhilips Medical Systems North America Co. · 2006
- Descendant · 5 generations on · 89 of its ownK083348 Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008
Showing 5 of 145 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 145 · See all- K972229Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 1997 · cites it directly143descendants
- K994210Inturis SuitePhilips Medical Systems, Inc. · 2000 · 2 generations on142descendants
- K022788Philips Harmony Release 1Philips Medical Systems North America Co. · 2002 · 3 generations on129descendants
- K061995XceleraPhilips Medical Systems North America Co. · 2006 · 4 generations on128descendants
- K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008 · 5 generations on89descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960043 | Kodak Cardiology Digital Archive & Review System | Jamieson Film Co. | 1996 | — |
| +1 | K972229 | Imageview Coronary Angiography Display and Review System | Heartware, Inc. | 1997 | — |
| +2 | K994210 | Inturis Suite | Philips Medical Systems, Inc. | 2000 | — |
| +3 | K022788 | Philips Harmony Release 1 | Philips Medical Systems North America Co. | 2002 | 2 |
| +4 | K061995 | Xcelera | Philips Medical Systems North America Co. | 2006 | — |
| +5 | K083348 | Image-Arena Applications | Tomtec Imaging Systems GmbH | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 13 | 0 |
| 2021 | 8 | 0 |
| 2022 | 12 | 0 |
| 2023 | 12 | 0 |
| 2024 | 12 | 0 |
| 2025 | 23 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (145)
See all 1452 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?
- Of its descendants, K972229 (Heartware, Inc., 1997) has gone furthest, with 143 descendants of its own.
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 | — |
https://510kreport.com/device/K960043 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960043: Kodak Cardiology Digital Archive & Review System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960043
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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