510(k) · Cleared
ClearedSienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LMD System, Digital Image Communications, Radiological
Cleared on Nov 12, 1997 as substantially equivalent to K953552 (Siemens Medical Solutions USA, Inc., 1995) and 2 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1993. 13 later devices descend from it.
- Decided
- Nov 12, 1997
- Review
- 83 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K924178 (1993). 5 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
- 1 generation backK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
- This deviceK973131 Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997
- 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 · cites it directly · 4 of its ownK043324 Aida with Dicom and HL7 InterfaceKARL STORZ Endoscopy-America, Inc. · 2005
- Descendant · 3 generations on · 2 of its ownK052461 Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · Recalled
- Descendant · 2 generations on · 1 of its ownK123426 Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K033831Sienet CosmosSiemens AG Medical Solutions · 2003 · cites it directly6descendants
- K042832Sienet Cosmos (Version V15A)Siemens AG Medical Solutions · 2004 · 2 generations on5descendants
- K043324Aida with Dicom and HL7 InterfaceKARL STORZ Endoscopy-America, Inc. · 2005 · cites it directly4descendants
- K052461Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · 3 generations on2descendants
- K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924178 | Medvision (TM) Imaging Software | Evergreen Technologies, Inc. | 1993 | — |
| −1 | K970064 | Amicas Web/Intranet Image Server | Autocyt Group, Inc. | 1997 | — |
| 0 (this device) | K973131 | Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway) | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +1 | K033831 | Sienet Cosmos | Siemens AG Medical Solutions | 2003 | 1 |
| +2 | K042832 | Sienet Cosmos (Version V15A) | Siemens AG Medical Solutions | 2004 | 3 |
| +1 | K043324 | Aida with Dicom and HL7 Interface | KARL STORZ Endoscopy-America, Inc. | 2005 | — |
| +3 | K052461 | Syngo Imaging Version V20A | Siemens AG Medical Solutions | 2005 | 3 |
| +2 | K123426 | Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS | Orpheus Medical, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 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? (4)
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 |
|---|---|---|---|
| * | K953552 | Sienet Spi Spooler Our OCR of the scanned summary read K953522, FDA’s number for Usci Ideal Ptca Kit (Ryder Intl. Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SIENET SPI Import/Export Spooler”. | 1995 |
| * | K970174 | Freepix/Pixpacs Dicom/HTTP GatewaySummary page 2…to the following commercially available devices: Siemens: SIENET SPI Import/Export Spooler [K953522] Mitra Imaging: HIS-SCP (Mitra Broker) PixeLinks: FreePix/PixPACS [K970174] Autocytgroup: Amicas Web Intranet Image Server [K970064] ‘The SIENET gateway products described in this 510(k) have the same i… | 1997 |
| * | K970064 | Amicas Web/Intranet Image ServerSummary page 2…: SIENET SPI Import/Export Spooler [K953522] Mitra Imaging: HIS-SCP (Mitra Broker) PixeLinks: FreePix/PixPACS [K970174] Autocytgroup: Amicas Web Intranet Image Server [K970064] ‘The SIENET gateway products described in this 510(k) have the same intended use and similar technical characteristics as the d… | 1997 |
| * | — | HIS-SCP (Mitra Broker) Named without a submission number |
What descends from it? (13)
See all 133 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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 5 ancestors has a recall.
- 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 | — |
What is it indicated for?
The SIENET MagicWeb and MagicLink I are medical communication devices (gateway devices). The MagicWeb is a web server intended to provide low-end image and report distribution. Images and reports can be viewed by accessing the server using commercially available Web Browsers. Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis.
The MagicLink I is a gateway connection between SIENET and RIS/HIS systems. Patient demographic information and examination data (text only) are transferred across the gateway. This device is an accessory to hospital information systems.
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/K973131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973131: Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973131
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