510(k) · Cleared
ClearedEnsphere Tempo Jetstream Workspace Cardiology Module
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 Feb 6, 2004 as substantially equivalent to K993946 (Adac Laboratories, 2000) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Feb 6, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K892358 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK892358 Pegasys Nuclear Medicine Imaging ComputerAdac Laboratories · 1989
- 2 generations backK993946 Pegasys UltraAdac Laboratories · 2000
- 1 generation backK021669 Physician's Desktop ReviewAdac Laboratories · 2002
- This deviceK040142 Ensphere Tempo Jetstream Workspace Cardiology ModuleAdac Laboratories · 2004
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 | K021669 | Physician's Desktop Review | Adac Laboratories | 2002 | — |
| 0 (this device) | K040142 | Ensphere Tempo Jetstream Workspace Cardiology Module | Adac Laboratories | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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…No. ADAC Laboratories Pegasys Ultra T 11 K993946 T K02 1669 ADAC Labor… | 2000 |
| * | K021669 | Physician's Desktop ReviewSummary page 1…atories Pegasys Ultra T 11 K993946 T K02 1669 ADAC Laboratories ENsphere 11 (Physician Desktop Review) D. Device Description:… | 2002 |
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 15 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- 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.
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?
ENSphereTM Tempo is a nuclear medicine image processing and display workstation that provides cardiology specific software applications used to process, analyze, and display medical images. The applications included with ENSphere Tempo may be used as a tool, by the Physician in interpreting Nuclear Cardiology procedures. ENSphere Tempo 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/K040142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040142: Ensphere Tempo Jetstream Workspace Cardiology Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040142
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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