510(k) · Cleared
Recalled · Class II · 2012Centricity Cardio Imaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Integrated IT Solutions · LLZ System, Image Processing, Radiological
Cleared on Nov 30, 2011 after an 85-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 30, 2011
- Review
- 85 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK112570 Centricity Cardio ImagingGe Healthcare Integrated IT Solutions · 2011
- Descendant · cites it directly · 2 of its ownK151850 McKesson CardiologyMckesson Israel, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK181080 McKesson CardiologyChange Healthcare Israel, Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK212528 Change Healthcare CardiologyChange Healthcare Israel, Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K112570 | Centricity Cardio Imaging | Ge Healthcare Integrated IT Solutions | 2011 | — |
| +1 | K151850 | McKesson Cardiology | Mckesson Israel, Ltd. | 2015 | — |
| +2 | K181080 | McKesson Cardiology | Change Healthcare Israel, Ltd. | 2018 | — |
| +3 | K212528 | Change Healthcare Cardiology | Change Healthcare Israel, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | — | Centricity* PACS-IW Named without a submission number | |
| * | — | Image Arena Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151850 | McKesson Cardiology | 2015 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2012 | Class II | Z-0034-2014 | Software design | GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K151850 (Mckesson Israel, Ltd., 2015) has gone furthest, with 2 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. 2011, 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?
Centricity* Cardio Imaging is a software only Picture Archiving and Communication System (PACS). It will be sold as a software only device to operate on general purpose computing hardware. Centricity* Cardio Imaging receives medical images and other information from various data sources, Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity* Cardio Imaging is…
Read the full statement (98 words)
Centricity* Cardio Imaging is a software only Picture Archiving and Communication System (PACS). It will be sold as a software only device to operate on general purpose computing hardware. Centricity* Cardio Imaging receives medical images and other information from various data sources, Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Centricity* Cardio Imaging is intended to assist trained professionals in the viewing, analysis, and diagnostic interpretation of images and other information. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians, and assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112570: Centricity Cardio Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112570
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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