510(k) · Cleared
ClearedSyngo MI Applications 2007A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 12, 2007 as substantially equivalent to K992731 (Siemens Medical Solutions USA, Inc., 1999) and 2 other predicates after a 17-day review. Its family tree reaches back 4 generations to 1995. 7 of the 98 devices in its family, counting itself, have a Class I recall. 86 later devices descend from it.
- Decided
- Jan 12, 2007
- Review
- 17 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K952674 (1995). 11 ancestors in all, the oldest K892358 (1989). 86 later devices descend from it, 2 citing it directly. 7 of the 98 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 3 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 2 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 1 generation backK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
- This deviceK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
- Descendant · cites it directly · 85 of its ownK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · cites it directly · 83 of its ownK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 66 of its ownK131634 SymbiaSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 65 of its ownK142006 Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 63 of its ownK162483 Symbia Intevo BoldSiemens Medical Solutions USA, Inc. · 2017
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 86 · See all- K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · cites it directly85descendants
- K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · cites it directly83descendants
- K131634SymbiaSiemens Medical Solutions USA, Inc. · 2013 · 2 generations on66descendants
- K142006Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · 3 generations on65descendants
- K162483Symbia Intevo BoldSiemens Medical Solutions USA, Inc. · 2017 · 4 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −3 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −2 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −1 | K023190 | E.Cam Computer / E.Soft Workstation | Siemens Medical Solutions USA, Inc. | 2002 | — |
| 0 (this device) | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +1 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
| +1 | K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | 2008 | 9 |
| +2 | K131634 | Symbia | Siemens Medical Solutions USA, Inc. | 2013 | 7 |
| +3 | K142006 | Symbia 6.0 | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
| +4 | K162483 | Symbia Intevo Bold | Siemens Medical Solutions USA, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 1 |
| 2010 | 1 | 0 |
| 2011 | 3 | 2 |
| 2012 | 1 | 1 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 1 |
| 2017 | 1 | 0 |
| 2018 | 4 | 1 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 10 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 10 | 0 |
| 2025 | 13 | 0 |
| 2026 | 11 | 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.
7 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? (3)
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 |
|---|---|---|---|
| * | K992731 | E.Cam ComputerSummary page 1…syngo MI Applications 2007A Proposed Device: 5. Predicate Devices: 510(k) #: Trade Name Manufacturer K992731 e. Cam Computer Siemens Medical Solution… | 1999 |
| * | K023190 | E.Cam Computer / E.Soft WorkstationSummary page 1…e. Cam Computer Siemens Medical Solutions USA, Inc. K023190 e.Cam Computer/ Siemens Medical e.soft Workstation Solution… | 2002 |
| * | K041166 | Siemens Enhanced Imaging SystemSummary page 1…e.Cam Computer/ Siemens Medical e.soft Workstation Solutions USA, Inc. K041166 Siemens Enhanced Siemens Medical Imaging System Solution… | 2004 |
What descends from it? (86)
See all 862 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 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.
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K111445Discovery NM 630GE Healthcare · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113350Brivo NM 615GE Healthcare · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121019Optima NM/CT 640GE Healthcare · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 8 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K072567 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 85 descendants of its own.
- 4 other devices also cite its predicate K992731.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Syngo Ml Applications 2007A is a software product intended for use with nuclear medicine applications. It is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.
It is used to detect or image the distribution of radionuclides in the body or organ(s) using the following techniques:
* planar imaging and processing
whole body imaging
* tomographic imaging
positron imaging by coincidence
positron imaging without coincidence up to 588 keV
display, process and fusion of nuclear medicine, SPECT, PET, CT and hybrid images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063826 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063826: Syngo MI Applications 2007A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063826
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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