510(k) · Cleared
ClearedVidiStar HeartView
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vidistar, LLC · LLZ System, Image Processing, Radiological
Cleared on Nov 25, 2015 as substantially equivalent to K130884 (Ge Medical Systems F.I. Haifa, 2013) after a 58-day review. Its family tree reaches back 9 generations to 2001.
- Decided
- Nov 25, 2015
- Review
- 58 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K010641 (2001). 22 ancestors in all, the oldest K914350 (1991). No later device cites it as a predicate yet.
- Root · 9 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 5 generations between
- 3 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 2 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 1 generation backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- This deviceK152822 VidiStar HeartViewVidistar, LLC · 2015
Show all 9 generations
- Root · 9 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 8 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 7 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 6 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 5 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 4 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 3 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 2 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 1 generation backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- This deviceK152822 VidiStar HeartViewVidistar, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −8 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −7 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −6 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −5 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −4 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −3 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −2 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −1 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| 0 (this device) | K152822 | VidiStar HeartView | Vidistar, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K130884 | Xeleris 3.1 Processing and Review WorkstationSummary page 4…CFR 892.2050 Regulatory Class: Class II Product Code: LLZ Predicate Device: Xeleris 3.1 Processing and Review Workstation (K130884) GE Healthcare Class II (21 CFR 892.2050; Product Code LLZ) Device… | 2013 |
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 14 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 22 ancestors have a recall of any class.
- 5 other devices also cite its predicate K130884.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The HeartView system is an internet-based application intended for use by nuclear medicine or radiology practitioners and referring physicians for the automated processing, review, quantification, and multidimensional review of nuclear medicine cardiology medical images, and specifically, radionuclides distributed in the body using planar and tomographic short axis images. HeartView may be used in various clinical settings including a hospital, clinic…
Read the full statement (155 words)
The HeartView system is an internet-based application intended for use by nuclear medicine or radiology practitioners and referring physicians for the automated processing, review, quantification, and multidimensional review of nuclear medicine cardiology medical images, and specifically, radionuclides distributed in the body using planar and tomographic short axis images.
HeartView may be used in various clinical settings including a hospital, clinic, imaging center, physician office, or remote locations.
The HeartView system implements algorithms for automatic quantification of myocardial perfusion single photon emission computerized tomography (SPECT) as well as quantification of ejection fraction, wall motion, and thickening from gated myocardial perfusion SPECT images.
Gated results are presented as 3D plots that can be used to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes, including quantitative assessments of cardiac function (e.g., systolic and diastolic function, regional wall thickening, wall motion, transient ischemic dilation, and phase analysis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152822: VidiStar HeartView.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152822
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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