510(k) · Cleared
Recalled · 2008Modification to Encompass
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 Jul 16, 2004 as substantially equivalent to K022292 (Agfa Corp., 2002) and 2 other predicates after a 101-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 16, 2004
- Review
- 101 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K913475 (1991). 12 ancestors in all. 1 later device descends from it, 1 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 deviceK040896 Modification to EncompassHeartlab, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK053043 Encompass Software PackageToshiba America Medical Systems, In.C · 2005
Most influential descendants
Showing 1 of 1 · See all- K053043Encompass Software PackageToshiba America Medical Systems, In.C · 2005 · cites it directly0descendants
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) | K040896 | Modification to Encompass | Heartlab, Inc. | 2004 | — |
| +1 | K053043 | Encompass Software Package | Toshiba America Medical Systems, In.C | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 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 |
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 21.6 · 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? (3)
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…and substantially equivalent to the following predicate devices currently in commercial distribution: Model Manufacturer Impax (k022292) Agfa Corp. EchoNet (k954860) Lockheed Martin Inturis Suite (k9942 10)… | 2002 |
| * | K954860 | EchonetSummary page 1…evices currently in commercial distribution: Model Manufacturer Impax (k022292) Agfa Corp. EchoNet (k954860) Lockheed Martin Inturis Suite (k9942 10) Philips Medical Systems… | 1995 |
| * | K994210 | Inturis SuiteSummary page 1…Manufacturer Impax (k022292) Agfa Corp. EchoNet (k954860) Lockheed Martin Inturis Suite (k9942 10) Philips Medical Systems ONJK: (KN S\\ INL)DROAD( \\IiS I… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053043 | Encompass Software Package | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 23, 2008 | Not classified | Z-0543-2009 | Software design | If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K053043 (Toshiba America Medical Systems, In.C, 2005) has gone furthest, with 0 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?
EncompassTM is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. EncompassTM is software comprised of modular software programs that run on standard "off-the-shelf' personal computers and servers running the Windows 2000/XP operating system. EncompassT M is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) data from…
Read the full statement (165 words)
EncompassTM is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. EncompassTM is software comprised of modular software programs that run on standard "off-the-shelf' personal computers and servers running the Windows 2000/XP operating system. EncompassT M 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. EncompassTM 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/K040896 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040896: Modification to Encompass.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040896
Report an extraction error
Are you the manufacturer?
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