510(k) · Cleared
Recalled · Class II · 2025Vericis Cardiovascular Image and Information System, Model 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camtronics Medical Systems · LLZ System, Image Processing, Radiological
Cleared on Aug 2, 2005 as substantially equivalent to K043146 (Mckesson Medical Imaging Company, 2005) after a 42-day review. Its family tree reaches back 3 generations to 1993. 10 later devices descend from it. It has been recalled 17 times.
- Decided
- Aug 2, 2005
- Review
- 42 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 17
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922164 (1993). 7 ancestors in all, the oldest K920319 (1992). 10 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
- 2 generations backK973959 Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareOlicon Imaging Systems, Inc. · 1997
- 1 generation backK043146 Horizon Medical ImagingMckesson Medical Imaging Company · 2005 · Recalled
- This deviceK051649 Vericis Cardiovascular Image and Information System, Model 4.0Camtronics Medical Systems · 2005
- Descendant · cites it directly · 7 of its ownK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 6 of its ownK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
- Descendant · 3 generations on · 5 of its ownK122205 EXINIExini Diagnostics AB · 2012
- Descendant · 4 generations on · 2 of its ownK191262 aBSIExini Diagnostics AB · 2019
- Descendant · 5 generations on · 1 of its ownK211655 aPROMISEExini Diagnostics AB · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · cites it directly7descendants
- K111319Ibis Explorer and Markup SoftwareMedqia · 2011 · 2 generations on6descendants
- K122205EXINIExini Diagnostics AB · 2012 · 3 generations on5descendants
- K191262aBSIExini Diagnostics AB · 2019 · 4 generations on2descendants
- K211655aPROMISEExini Diagnostics AB · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922164 | Raytel Digital Imaging Systems | Olicon Imaging Systems, Inc. | 1993 | — |
| −2 | K973959 | Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software | Olicon Imaging Systems, Inc. | 1997 | — |
| −1 | K043146 | Horizon Medical Imaging | Mckesson Medical Imaging Company | 2005 | 11 |
| 0 (this device) | K051649 | Vericis Cardiovascular Image and Information System, Model 4.0 | Camtronics Medical Systems | 2005 | — |
| +1 | K053133 | Syngo Dynamics, Version 5.0 | Siemens Medical Solutions USA, Inc. | 2005 | 2 |
| +2 | K111319 | Ibis Explorer and Markup Software | Medqia | 2011 | — |
| +3 | K122205 | EXINI | Exini Diagnostics AB | 2012 | — |
| +4 | K191262 | aBSI | Exini Diagnostics AB | 2019 | — |
| +5 | K211655 | aPROMISE | Exini Diagnostics AB | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K043146 | Horizon Medical ImagingSummary page 1…e: System, Image Processing, Radiological Regulation Class: II Product Code: LZZ C. Predicate Devices McKesson Horizon Medical Imaging (K043146) D. Device Description The VERICIS is an integrated cardiovascular information system classified as a picture… | 2005 |
| † | K955519 | Analytical Review Station | 1996 |
| † | K992259 | Echocardiography System Series 95000 | 1999 |
What descends from it? (10)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 19, 2025 | Class II | Z-1401-2025 | Software design | When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent… |
| Feb 19, 2025 | Class II | Z-1398-2025 | Software design | When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent… |
| Feb 19, 2025 | Class II | Z-1399-2025 | Software design | When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent… |
| Feb 19, 2025 | Class II | Z-1400-2025 | Software design | When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent… |
| May 8, 2020 | Class II | Z-2403-2020 | Software Design Change | An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative. |
| Apr 13, 2016 | Class II | Z-2123-2017 | Software design | Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced. |
| Apr 4, 2016 | Class II | Z-1486-2017 | Software design | Cardio study list does not show STAT studies without refreshing. |
| Apr 4, 2016 | Class II | Z-1415-2017 | Software design | A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt. |
| Apr 4, 2016 | Class II | Z-1403-2017 | Software design | When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure. |
| Mar 28, 2016 | Class II | Z-0729-2017 | Software design | If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still… |
| Mar 28, 2016 | Class II | Z-1046-2017 | Software design | If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review… |
| Feb 9, 2016 | Class II | Z-2709-2016 | Software design | A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR). |
| Jan 30, 2016 | Class II | Z-2865-2016 | Software design | Patient information in the header is only found on the first page of the report and not on the subsequent pages. |
| Oct 26, 2015 | Class II | Z-0555-2016 | Process control | The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house. |
| Oct 1, 2015 | Class II | Z-0730-2017 | Software design | Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost. |
| Sep 22, 2015 | Class II | Z-1496-2017 | Process design | For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and… |
| Sep 22, 2015 | Class II | Z-1517-2017 | Software design | Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation. |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K053133 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K043146.
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 | — |
What is it indicated for?
VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data. VERICIS is intended to allow users to review diagnostic and non-diagnostic…
Read the full statement (215 words)
VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data. VERICIS is intended to allow users to review diagnostic and non-diagnostic quality images, annotate studies, perform digital subtraction on images, to perform quantitative measurements on images (including but not limited to quantitative coronary analysis, left ventricular analysis, time, area, length, velocity, angle, volume, and velocity-time integrals), to generate physician-generated clinical reports (via structure reporting and template based tools), and to store this information in a database.
*VERICIS is software comprised of modules that perform under standard "off-the-shelf' personal computers and servers running the Microsoft Windows 2000/2003/XP operating systems. eVERICIS is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) image data files from multiple modalities. It accepts text data using other standards-based formats including but not limited to HL7 and XML. eVERICIS is an Intemet/Intranet network system that is designed for small and large, multi-user environments. The VERICIS network structure (including server and workstations) provides for the system's database management, storage, printing, and all DICOM/HL-7 interface services.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051649: Vericis Cardiovascular Image and Information System, Model 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051649
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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