510(k) · Cleared
ClearedJetpack 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 Apr 21, 2011 as substantially equivalent to K080961 (Philips Nuclear Medicine, Inc., 2008) after a 9-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Apr 21, 2011
- Review
- 9 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K892358 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK111024 Jetpack 2.0Philips Medical Systems (Cleveland), Inc. · 2011
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) | K111024 | Jetpack 2.0 | Philips Medical Systems (Cleveland), Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 21.6 · 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 |
|---|---|---|---|
| * | K080961 | NM Application SuiteSummary page 1…10(k) No. Philips Medical Systems NM Application Suite K080961 (Cleveland), Inc. D. Device Description: JETPack 2.0 is a Windows®-based Nuclear Medicine suit… | 2008 |
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 22 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 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 gamma
camera. JETPack 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/K111024 · printed Nov 3, 2026
Cite this page
510(k) Report. “K111024: Jetpack 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K111024
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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