510(k) · Cleared
Recalled · Class II · 2016Agfa Heartlab Cardiovascular
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartlab, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 18, 2005 as substantially equivalent to K022292 (Agfa Corp., 2002) and 1 other predicate after a 17-day review. Its family tree reaches back 4 generations to 1991. 9 later devices descend from it. It has been recalled 22 times.
- Decided
- Feb 18, 2005
- Review
- 17 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 22
- Predicates
- 2
Its longest line of descent runs back 4 generations to K913475 (1991). 11 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 3 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 2 generations backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
- 1 generation backK022292 Impax Diagnostic Display Station,Impax Clinical Review Station,Impax…Agfa Corp. · 2002 · Recalled
- This deviceK050228 Agfa Heartlab CardiovascularHeartlab, Inc. · 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 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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 |
|---|---|---|---|---|---|
| −4 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −3 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −2 | K971965 | Philips Easyvision | Philips Medical Systems, Inc. | 1998 | — |
| −1 | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for… | Agfa Corp. | 2002 | 9 |
| 0 (this device) | K050228 | Agfa Heartlab Cardiovascular | Heartlab, Inc. | 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 |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 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? (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 |
|---|---|---|---|
| * | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Summary page 1…mparable and substantially equivalent to the following predicate devices currently in commercial distribution: Model Manufacturer Impax (k022292) Agfa Corp. Inturis Suite (k9942 10) Philips Medical Systems O… | 2002 |
| * | K994210 | Inturis SuiteSummary page 1…edicate devices currently in commercial distribution: Model Manufacturer Impax (k022292) Agfa Corp. Inturis Suite (k9942 10) Philips Medical Systems ONE CROSSWIND ROAD · WESTERLY, RI - 02891… | 2000 |
What descends from it? (9)
2 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 |
|---|---|---|---|---|
| Dec 22, 2016 | Class II | Z-2652-2017 | Software design | A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm. |
| Sep 1, 2015 | Class II | Z-0283-2016 | Software design | Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct. |
| Apr 30, 2014 | Class II | Z-1662-2014 | Software design | Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service. |
| Mar 15, 2013 | Class II | Z-1070-2013 | Software design | Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system. |
| Mar 15, 2013 | Class II | Z-1069-2013 | Software design | Software design error in IMPAX CV 7.8 SU3 |
| Aug 9, 2012 | Class II | Z-2252-2012 | Process design | Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS). |
| Jul 27, 2012 | Class II | Z-2184-2012 | Software change control | Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report. |
| Jul 10, 2012 | Class II | Z-2069-2012 | Error in labeling | When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report. |
| Jun 6, 2011 | Not classified | Z-0211-2012 | Software design | Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable. |
| Jun 6, 2011 | Not classified | Z-0212-2012 | Pending | Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR). |
| Jun 6, 2011 | Not classified | Z-0272-2012 | Software design | Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it. |
| Mar 21, 2011 | Not classified | Z-2552-2011 | Other | Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper calibration. |
| Feb 10, 2011 | Not classified | Z-1676-2011 | Device Design | A discrepancy in the validation testing which resulted in the product not performing as intended. |
| Jan 27, 2011 | Not classified | Z-1434-2011 | Other | Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports. |
| Jun 11, 2010 | Not classified | Z-2112-2010 | Other | Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators. |
| Apr 15, 2009 | Not classified | Z-1435-2011 | Other | User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM. |
| Dec 24, 2008 | Not classified | Z-0945-2009 | Software design | Polling procedure may fail when multiple merge/split is carried out. |
| Feb 22, 2008 | Not classified | Z-1349-2008 | Software design | Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology… |
| Jul 27, 2007 | Not classified | Z-1242-2008 | Software design | Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured. |
| Jun 21, 2007 | Not classified | Z-1241-2008 | Software design | MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient. |
| May 14, 2007 | Not classified | Z-1243-2008 | Software change control | Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost. |
| May 14, 2007 | Not classified | Z-1244-2008 | Software change control | Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost. |
The 5 latest of 22 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 14 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K053133 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 7 descendants of its own.
- 11 other devices also cite its predicate K022292.
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?
Ascentia TM (formally EncompassTM) is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. AscentiaTM is personal software comprised of modular software programs that run on standard "off-the-shelf" computers and servers running the Windows 2000/2003/XP operating system. AscentiaTM is image data storage and display software that accepts DICOM (Digital Imaging and Communications in…
Read the full statement (167 words)
Ascentia TM (formally EncompassTM) is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. AscentiaTM is personal software comprised of modular software programs that run on standard "off-the-shelf" computers and servers running the Windows 2000/2003/XP operating system. AscentiaTM is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging transfer. The system provides the capability to; consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative measurements on both cath and ultrasound images, perform quantitative analysis on cath images, generate and review patient reports with additional measurement and report writer capabilities and provides accessible digital image archive. AscentiaTM is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050228: Agfa Heartlab Cardiovascular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050228
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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