510(k) · Cleared
ClearedClarify DL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Israel, Functional Imaging · LLZ System, Image Processing, Radiological
Cleared on Jan 3, 2025 as substantially equivalent to K221680 (GE Healthcare, 2023) and 1 other predicate after a 235-day review. Its family tree reaches back 12 generations to 2001. 6 of the 59 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 3, 2025
- Review
- 235 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K010641 (2001). 58 ancestors in all, the oldest K892358 (1989). No later device cites it as a predicate yet. 6 of the 59 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 8 generations between
- 3 generations backK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- 2 generations backK201103 Xeleris V Processing and Review SystemsGE Healthcare · 2020
- 1 generation backK221680 Xeleris V Processing and Review SystemGE Healthcare · 2023
- This deviceK241350 Clarify DLGe Medical Systems Israel, Functional Imaging · 2025
Show all 12 generations
- Root · 12 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 11 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 10 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 9 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 8 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 7 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 6 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 5 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 4 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 3 generations backK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- 2 generations backK201103 Xeleris V Processing and Review SystemsGE Healthcare · 2020
- 1 generation backK221680 Xeleris V Processing and Review SystemGE Healthcare · 2023
- This deviceK241350 Clarify DLGe Medical Systems Israel, Functional Imaging · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −11 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −10 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −9 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −8 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −7 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −6 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −5 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −4 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| −3 | K153355 | Xeleris 4.0 Processing and Review Workstation | GE Healthcare | 2016 | — |
| −2 | K201103 | Xeleris V Processing and Review Systems | GE Healthcare | 2020 | — |
| −1 | K221680 | Xeleris V Processing and Review System | GE Healthcare | 2023 | — |
| 0 (this device) | K241350 | Clarify DL | Ge Medical Systems Israel, Functional Imaging | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1995 | 3 | 1 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 1 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 1 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 1 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 1 |
| 2010 | 1 | 0 |
| 2016 | 1 | 1 |
| 2021 | 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.
6 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K221680 | Xeleris V Processing and Review SystemSummary page 5…Xeleris V Processing and Review System Manufacturer: GE Medical Systems Israel, Functional Imaging 510(k) Number: K221680 Regulation Number/ Product Code: 21CFR 892.2050 / LLZ Predicate Device 2 Device Name: StarGuid… | 2023 |
| * | K210173 | StarGuideSummary page 5…e Name: StarGuide Manufacturer: GE Medical Systems Israel, Functional Imaging 510(k) Number: K210173 Regulation Number/ Product Code: 21CFR 892.1200 / KPS 1… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 2 generations back · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall
- K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 3 generations back · ◆ in the 2009 ancestors bar of FIG. 12 Class I recalls
- K052434Hawkeye 4 Option for Dual-Head Variable Angle Gamma CameraGE Medical Systems · 2005 · 4 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 5 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
- K953801VaricamElscint, Inc. · 1995 · 5 generations back · ◆ in the 1995 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 29 of the 58 ancestors have a recall of any class; 6 have a Class I recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Clarify DL is a deep learning-based image reconstruction method intended to reduce noise and improve image quality of Nuclear Medicine bone SPECT scintigraphy images. Clarify DL may be used for patients of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241350: Clarify DL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241350
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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