510(k) · Cleared
ClearedPhysician's Desktop Review
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 Jun 5, 2002 as substantially equivalent to K993946 (Adac Laboratories, 2000) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Jun 5, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K892358 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK892358 Pegasys Nuclear Medicine Imaging ComputerAdac Laboratories · 1989
- 1 generation backK993946 Pegasys UltraAdac Laboratories · 2000
- This deviceK021669 Physician's Desktop ReviewAdac Laboratories · 2002
- Descendant · cites it directly · 0 of its ownK040142 Ensphere Tempo Jetstream Workspace Cardiology ModuleAdac Laboratories · 2004
Most influential descendants
Showing 1 of 1 · See all- K040142Ensphere Tempo Jetstream Workspace Cardiology ModuleAdac Laboratories · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K892358 | Pegasys Nuclear Medicine Imaging Computer | Adac Laboratories | 1989 | — |
| −1 | K993946 | Pegasys Ultra | Adac Laboratories | 2000 | — |
| 0 (this device) | K021669 | Physician's Desktop Review | Adac Laboratories | 2002 | — |
| +1 | 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 |
Descendants 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 21.5 · 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 Pegasys InTouch (WebViewTbf) K974474 D. Device Description:… | 2000 |
| * | K974474 | Pegasys IntouchSummary page 1…No. ADAC Laboratories Pegasys UltraTM K993946 ADAC Laboratories Pegasys InTouch (WebViewTbf) K974474 D. Device Description: Physician’s Desktop Review (PDT) is a Windows@-basedphysician… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040142 | Ensphere Tempo Jetstream Workspace Cardiology Module | 2004 | 0 |
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 13 years and passes through 1 company; a new generation was cleared every 10.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K040142 (Adac Laboratories, 2004) has gone furthest, with 0 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.
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?
Physician’s Desktop Review is a medical image display workstation that provides software applications used for review and interpretation of medical imageddata. The results obtdrned may be used as a tool in interpretation of data derived from any medical imaging procedures. The Physician’s Desktop Review system should only be operated by qualified healthcare professionals (e.g., radiologists, cardiologists, oncologists, or general nuclear medicine physicians) trained in the use of medical imaging equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021669: Physician's Desktop Review.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021669
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