510(k) · Cleared
ClearedPegasys Ultra
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 Mar 9, 2000 as substantially equivalent to K892358 (Adac Laboratories, 1989) after a 111-day review. Its family tree reaches back 1 generation to 1989. 30 later devices descend from it.
- Decided
- Mar 9, 2000
- Review
- 111 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K892358 (1989). 30 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK892358 Pegasys Nuclear Medicine Imaging ComputerAdac Laboratories · 1989
- This deviceK993946 Pegasys UltraAdac Laboratories · 2000
- Descendant · cites it directly · 26 of its ownK061029 Jetstream WorkspaceAdac Laboratories · 2006 · Recalled
- Descendant · cites it directly · 12 of its ownK080961 NM Application SuitePhilips Nuclear Medicine, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 10 of its ownK072468 Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · Recalled
- Descendant · 3 generations on · 9 of its ownK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
- Descendant · 2 generations on · 9 of its ownK111336 EBW NM 2.0Philips Medical Systems (Cleveland), Inc. · 2011
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K061029Jetstream WorkspaceAdac Laboratories · 2006 · cites it directly26descendants
- K080961NM Application SuitePhilips Nuclear Medicine, Inc. · 2008 · cites it directly12descendants
- K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · 2 generations on10descendants
- K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011 · 3 generations on9descendants
- K111336EBW NM 2.0Philips Medical Systems (Cleveland), Inc. · 2011 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892358 | Pegasys Nuclear Medicine Imaging Computer | Adac Laboratories | 1989 | — |
| 0 (this device) | K993946 | Pegasys Ultra | Adac Laboratories | 2000 | — |
| +1 | K061029 | Jetstream Workspace | Adac Laboratories | 2006 | 1 |
| +1 | K080961 | NM Application Suite | Philips Nuclear Medicine, Inc. | 2008 | 1 |
| +2 | K072468 | Modification to D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2007 | 1 |
| +3 | K110507 | Cardiac Scanner and Processing System | Spectrum Dynamics (Israel), Ltd. | 2011 | — |
| +2 | K111336 | EBW NM 2.0 | Philips Medical Systems (Cleveland), Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K892358 | Pegasys Nuclear Medicine Imaging ComputerSummary page 2…Workstation Classification name: Picture Archiving and Communications System (per 21CFR section 892.2050) Predicate Devices: PEGASYS Nuclear Medicine Imaging Computer, K892358 Device Description: Pegasys Ultra is a UNIX-based SUN display workstation and central processor, a high resolution processing c… | 1989 |
What descends from it? (30)
See all 305 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?
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?
Pegasys Ultra is a nuclear medicine image processing and display workstation 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 Pegasys Ultra system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993946: Pegasys Ultra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993946
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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