510(k) · Cleared
ClearedQuantitative Blood Pool Spect (QBS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · LLZ System, Image Processing, Radiological
Cleared on Aug 6, 2002 as substantially equivalent to K003264 (Ge Medical Systems F.I. Haifa, 2000) after a 12-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Aug 6, 2002
- Review
- 12 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003264 (2000). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003264 QPS/BPGS/Moco Processing Applications for Entegra WorkstationGe Medical Systems F.I. Haifa · 2000
- This deviceK022428 Quantitative Blood Pool Spect (QBS)Adac Laboratories · 2002
- Descendant · cites it directly · 3 of its ownK040326 Autoquant PlusAdac Laboratories · 2004
- Descendant · 2 generations on · 1 of its ownK060020 Autoquant PlusAdac Laboratories · 2006
- Descendant · 2 generations on · 0 of its ownK213731 EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsEver Fortune.Ai, Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK100714 CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01Cedars-Sinai Medical Center · 2011
Most influential descendants
Showing 4 of 4 · See all- K040326Autoquant PlusAdac Laboratories · 2004 · cites it directly3descendants
- K060020Autoquant PlusAdac Laboratories · 2006 · 2 generations on1descendant
- K213731EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsEver Fortune.Ai, Co., Ltd. · 2022 · 2 generations on0descendants
- K100714CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01Cedars-Sinai Medical Center · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003264 | QPS/BPGS/Moco Processing Applications for Entegra Workstation | Ge Medical Systems F.I. Haifa | 2000 | — |
| 0 (this device) | K022428 | Quantitative Blood Pool Spect (QBS) | Adac Laboratories | 2002 | — |
| +1 | K040326 | Autoquant Plus | Adac Laboratories | 2004 | — |
| +2 | K060020 | Autoquant Plus | Adac Laboratories | 2006 | — |
| +2 | K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | Ever Fortune.Ai, Co., Ltd. | 2022 | — |
| +3 | K100714 | CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01 | Cedars-Sinai Medical Center | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K003264 | QPS/BPGS/Moco Processing Applications for Entegra WorkstationSummary page 2…echnological Comparison: The Quantitative Blood Pool SPECT (QBS) and the QPS/BPGS/MoCo Processing Applications for eNTEGFL4 Workstation (K003264) have similar indications for use and overall function and perform in a similar manner with respe… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040326 | Autoquant Plus | 2004 | 3 |
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?
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?
Quantitative Blood Pool SPECT (QBS) is a standalone software application for the display and analysis of gated short axis blood pool (red blood cells, RBC) SPECT datasets. The results provided by QBS should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022428 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022428: Quantitative Blood Pool Spect (QBS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022428
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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