510(k) · Cleared
ClearedEncompass Software Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · LLZ System, Image Processing, Radiological
Cleared on Nov 18, 2005 as substantially equivalent to K040896 (Heartlab, Inc., 2004) and 2 other predicates after a 21-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Nov 18, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K894632 (1989). 54 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 7 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 6 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 5 generations backK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
- 4 generations backK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- 3 generations backK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
- 2 generations backK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
- 1 generation backK041499 Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation · 2004 · Recalled
- This deviceK053043 Encompass Software PackageToshiba America Medical Systems, In.C · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −7 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −6 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −5 | K991858 | Ssa-390A/Power Vision 8000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −4 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| −3 | K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2002 | 1 |
| −2 | K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2003 | — |
| −1 | K041499 | Ssa-770A, Aplio Version 5.5 | Toshibamedical Systems Corporation | 2004 | 3 |
| 0 (this device) | 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 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K040896 | Modification to EncompassSummary page 1…Software Regulatory Class: Class II Performance Standard: none Predicate Device(s): Agfa Corp. Encompass [K040896], Toshiba SSA- 770A [K041499], General Electric Vivid 7 with TSI… | 2004 |
| * | K041499 | Ssa-770A, Aplio Version 5.5Summary page 1…ass II Performance Standard: none Predicate Device(s): Agfa Corp. Encompass [K040896], Toshiba SSA- 770A [K041499], General Electric Vivid 7 with TSI [K031663] Reason For Submission new device (… | 2004 |
| * | K031663 | GE Vivid 7, Model FC0003XXSummary page 1…Agfa Corp. Encompass [K040896], Toshiba SSA- 770A [K041499], General Electric Vivid 7 with TSI [K031663] Reason For Submission new device (software) Description of this Device: These software packages are to be applie… | 2003 |
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 16 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 54 ancestors have a recall of any class.
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?
Using the software listed to post-process images, various analysis and reconstruction can be initiated by the user to obtain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are: * URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. * URFR-001A: Three-dimensional image…
Read the full statement (156 words)
Using the software listed to post-process images, various analysis and reconstruction can be initiated by the user to obtain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are:
* URSE-001A: Stress Echo analysis of the ultrasound diagnostic images.
* URFR-001A: Three-dimensional image reconstruction from the ultrasound diagnostic images for abdominal, small organs and peripheral vascular.
* URTQ-001A: Following analysis from the TDI (Tissue Doppler Image) from the ultrasound diagnostic images.
- Gray scale (display of only black-and-white images)
- Velocity display (display of the velocity after angle correction and smoothing)
- Display of the velocity gradient based on the velocity image
- Display of the degree of myocardial strain based on the velocity image
- Display of the displacement based on the velocity image
- Display of the dyssynchrony imaging based on the above imaging methods
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053043: Encompass Software Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053043
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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