510(k) · Cleared
ClearedEBW NM 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · LLZ System, Image Processing, Radiological
Cleared on May 24, 2011 as substantially equivalent to K080961 (Philips Nuclear Medicine, Inc., 2008) and 1 other predicate after a 12-day review. Its family tree reaches back 4 generations to 1989. 9 later devices descend from it.
- Decided
- May 24, 2011
- Review
- 12 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K892358 (1989). 8 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK892358 Pegasys Nuclear Medicine Imaging ComputerAdac Laboratories · 1989
- 3 generations backK993946 Pegasys UltraAdac Laboratories · 2000
- 2 generations backK061029 Jetstream WorkspaceAdac Laboratories · 2006 · Recalled
- 1 generation backK080961 NM Application SuitePhilips Nuclear Medicine, Inc. · 2008 · Recalled
- This deviceK111336 EBW NM 2.0Philips Medical Systems (Cleveland), Inc. · 2011
- Descendant · cites it directly · 5 of its ownK162955 Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. · 2016
- Descendant · 2 generations on · 3 of its ownK210831 OnQ NeuroCortechs Labs, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK151212 Ziostation2Qi Imaging, LLC · 2015
- Descendant · 3 generations on · 1 of its ownK250416 GBrain MRIGalileo Cds, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. · 2016 · cites it directly5descendants
- K210831OnQ NeuroCortechs Labs, Inc. · 2021 · 2 generations on3descendants
- K151212Ziostation2Qi Imaging, LLC · 2015 · cites it directly2descendants
- K250416GBrain MRIGalileo Cds, Inc. · 2025 · 3 generations on1descendant
- K181892Ziostation2Ziosoft, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K892358 | Pegasys Nuclear Medicine Imaging Computer | Adac Laboratories | 1989 | — |
| −3 | K993946 | Pegasys Ultra | Adac Laboratories | 2000 | — |
| −2 | K061029 | Jetstream Workspace | Adac Laboratories | 2006 | 1 |
| −1 | K080961 | NM Application Suite | Philips Nuclear Medicine, Inc. | 2008 | 1 |
| 0 (this device) | K111336 | EBW NM 2.0 | Philips Medical Systems (Cleveland), Inc. | 2011 | — |
| +1 | K162955 | Multi-Modality Tumor Tracking (MMTT) application | Philips Medical Systems Nederland B.V. | 2016 | — |
| +2 | K210831 | OnQ Neuro | Cortechs Labs, Inc. | 2021 | — |
| +1 | K151212 | Ziostation2 | Qi Imaging, LLC | 2015 | — |
| +3 | K250416 | GBrain MRI | Galileo Cds, Inc. | 2025 | — |
| +2 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K080961 | NM Application SuiteSummary page 1…510(k) No. Philips Medical Systems NM Application Suite K080961 (Cleveland), Inc. Philips Medical Systems AutoSPECT K(090403 (Cle… | 2008 |
| * | K090403 | AutospectSummary page 2…cal comparison, and system performance. The subset of applications, AutoSPECT Pro, is substantially equivalent to the AutoSPECT predicate device (K090403) based on similar intended use and technological comparison.… | 2009 |
What descends from it? (9)
2 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)
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 22 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K162955 (Philips Medical Systems Nederland B.V., 2016) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K080961.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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
structure. The data processed may be derived from any nuclear
medicine camera. EBW NM 2.0 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/K111336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111336: EBW NM 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111336
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