510(k) · Cleared
Recalled · 2007Sienet Archive Server, Isa I, Isa II Storage Serve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Gammasonics, Inc. · LMD System, Digital Image Communications, Radiological
Cleared on Mar 30, 1992 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled once.
- Decided
- Mar 30, 1992
- Review
- 67 days
- Class
- Class I
- Product code
- LMD
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK920310 Sienet Archive Server, Isa I, Isa II Storage ServeSiemens Gammasonics, Inc. · 1992
- Descendant · cites it directly · 6 of its ownK033831 Sienet CosmosSiemens AG Medical Solutions · 2003 · Recalled
- Descendant · 2 generations on · 5 of its ownK042832 Sienet Cosmos (Version V15A)Siemens AG Medical Solutions · 2004 · Recalled
- Descendant · 3 generations on · 2 of its ownK052461 Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · Recalled
- Descendant · 3 generations on · 1 of its ownK070755 InterworksAvreo, Inc. · 2007
- Descendant · 4 generations on · 0 of its ownK141556 Avreo Interworks SystemAvreo, Inc. · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K033831Sienet CosmosSiemens AG Medical Solutions · 2003 · cites it directly6descendants
- K042832Sienet Cosmos (Version V15A)Siemens AG Medical Solutions · 2004 · 2 generations on5descendants
- K052461Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · 3 generations on2descendants
- K070755InterworksAvreo, Inc. · 2007 · 3 generations on1descendant
- K141556Avreo Interworks SystemAvreo, Inc. · 2014 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920310 | Sienet Archive Server, Isa I, Isa II Storage Serve | Siemens Gammasonics, Inc. | 1992 | — |
| +1 | K033831 | Sienet Cosmos | Siemens AG Medical Solutions | 2003 | 1 |
| +2 | K042832 | Sienet Cosmos (Version V15A) | Siemens AG Medical Solutions | 2004 | 3 |
| +3 | K052461 | Syngo Imaging Version V20A | Siemens AG Medical Solutions | 2005 | 3 |
| +3 | K070755 | Interworks | Avreo, Inc. | 2007 | — |
| +4 | K141556 | Avreo Interworks System | Avreo, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033831 | Sienet Cosmos | 2003 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 2, 2007 | Not classified | Z-0890-2007 | Other | System could crash and result in data loss. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033831 (Siemens AG Medical Solutions, 2003) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LMD devicesLMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMD
FDA has decided no LMD device since 2007.
Median 510(k) review, days · LMD
Too few LMD 510(k)s in any year since 2007 to give a median.
Recalls per year · LMD
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMD
16in 2025
MAUDE reports naming product code LMD, 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 | 0 | — | 2 | 1 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 2 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K920310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920310: Sienet Archive Server, Isa I, Isa II Storage Serve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920310
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026