510(k) · Cleared
ClearedMerge Cardio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merge Healthcare Incorporated · LLZ System, Image Processing, Radiological
Cleared on Sep 20, 2019 as substantially equivalent to K051649 (Camtronics Medical Systems, 2005) after a 29-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Sep 20, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K922164 (1993). 8 ancestors in all, the oldest K920319 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
- 3 generations backK973959 Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareOlicon Imaging Systems, Inc. · 1997
- 2 generations backK043146 Horizon Medical ImagingMckesson Medical Imaging Company · 2005 · Recalled
- 1 generation backK051649 Vericis Cardiovascular Image and Information System, Model 4.0Camtronics Medical Systems · 2005 · Recalled
- This deviceK192276 Merge CardioMerge Healthcare Incorporated · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922164 | Raytel Digital Imaging Systems | Olicon Imaging Systems, Inc. | 1993 | — |
| −3 | K973959 | Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software | Olicon Imaging Systems, Inc. | 1997 | — |
| −2 | K043146 | Horizon Medical Imaging | Mckesson Medical Imaging Company | 2005 | 11 |
| −1 | K051649 | Vericis Cardiovascular Image and Information System, Model 4.0 | Camtronics Medical Systems | 2005 | 17 |
| 0 (this device) | K192276 | Merge Cardio | Merge Healthcare Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K051649 | Vericis Cardiovascular Image and Information System, Model 4.0Summary page 6…uct Code: LLZ Device Class: Class II Predicate Device(s) Predicate Device: Vericis Cardiovascular Image and Information System K051649 Device Description Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular informa… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K051649.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Merge Cardio software product is an integrated multi-modality image and information system designed to perform the necessary functions required for import, export, review, analysis, quantification, reporting, and database management of digital cardiovascular images, documents, and data related to cardiology. Merge Cardio offers support for third-party applications in order to enable the use of commercially available tools and specified applications for…
Read the full statement (126 words)
Merge Cardio software product is an integrated multi-modality image and information system designed to perform the
necessary functions required for import, export, review, analysis, quantification, reporting, and database management of
digital cardiovascular images, documents, and data related to cardiology. Merge Cardio offers support for third-party
applications in order to enable the use of commercially available tools and specified applications for analysis,
quantification, and reporting. Merge Cardio software runs on standard information technology hardware and software, using
standard information technology operating systems and user interfaces. Communication and data exchange are done using
standard protocols. The modular design allows configurability to tailor the image import and communications solution to the
needs of the user. The number of modalities and reporting and/or viewing sites can be configured per system.
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/K192276 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192276: Merge Cardio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192276
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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