510(k) · Cleared
Recalled · 2011NM Application Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Nuclear Medicine, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 18, 2008 as substantially equivalent to K993946 (Adac Laboratories, 2000) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1989. 12 later devices descend from it. It has been recalled once.
- Decided
- Apr 18, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K892358 (1989). 4 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK892358 Pegasys Nuclear Medicine Imaging ComputerAdac Laboratories · 1989
- 2 generations backK993946 Pegasys UltraAdac Laboratories · 2000
- 1 generation backK061029 Jetstream WorkspaceAdac Laboratories · 2006 · Recalled
- This deviceK080961 NM Application SuitePhilips Nuclear Medicine, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK111336 EBW NM 2.0Philips Medical Systems (Cleveland), Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK162955 Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. · 2016
- Descendant · 3 generations on · 3 of its ownK210831 OnQ NeuroCortechs Labs, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK151212 Ziostation2Qi Imaging, LLC · 2015
- Descendant · 4 generations on · 1 of its ownK250416 GBrain MRIGalileo Cds, Inc. · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K111336EBW NM 2.0Philips Medical Systems (Cleveland), Inc. · 2011 · cites it directly9descendants
- K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. · 2016 · 2 generations on5descendants
- K210831OnQ NeuroCortechs Labs, Inc. · 2021 · 3 generations on3descendants
- K151212Ziostation2Qi Imaging, LLC · 2015 · 2 generations on2descendants
- K250416GBrain MRIGalileo Cds, Inc. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K892358 | Pegasys Nuclear Medicine Imaging Computer | Adac Laboratories | 1989 | — |
| −2 | K993946 | Pegasys Ultra | Adac Laboratories | 2000 | — |
| −1 | K061029 | Jetstream Workspace | Adac Laboratories | 2006 | 1 |
| 0 (this device) | K080961 | NM Application Suite | Philips Nuclear Medicine, Inc. | 2008 | — |
| +1 | K111336 | EBW NM 2.0 | Philips Medical Systems (Cleveland), Inc. | 2011 | — |
| +2 | K162955 | Multi-Modality Tumor Tracking (MMTT) application | Philips Medical Systems Nederland B.V. | 2016 | — |
| +3 | K210831 | OnQ Neuro | Cortechs Labs, Inc. | 2021 | — |
| +2 | K151212 | Ziostation2 | Qi Imaging, LLC | 2015 | — |
| +4 | K250416 | GBrain MRI | Galileo Cds, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K993946 | Pegasys UltraSummary page 1…Manufacturer Product Name 510(k) No. ADAC Laboratories Pegasys UltraTm K993946 ADAC Laboratories JETStreamg Workspace K06 1029 D. Device Description:… | 2000 |
| * | K061029 | Jetstream WorkspaceSummary page 1…No. ADAC Laboratories Pegasys UltraTm K993946 ADAC Laboratories JETStreamg Workspace K06 1029 D. Device Description: The NM Application Suite is a Windows(&-based Nuclear Medicine suite of… | 2006 |
What descends from it? (12)
See all 123 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 |
|---|---|---|---|---|
| Sep 15, 2011 | Not classified | Z-0182-2012 | Software design | A problem related to a software error has been detected in the Philips Multiple Gated Radionuclide Angiocardiography (MUGA) application. A false negative interpretation due to a falsely elevated ejection fraction or a false positive… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K111336 (Philips Medical Systems (Cleveland), Inc., 2011) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K993946.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
A nuclear medicine image display and processing application suite that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine gamma camera. The NM Application Suite should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080961: NM Application Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080961
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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