510(k) · Cleared
ClearedIivs Integrated Image Viewing Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terarecon,Inc. · LMD System, Digital Image Communications, Radiological
Cleared on May 26, 2000 as substantially equivalent to K961023 (Accuimage, Inc., 1996) after a 156-day review. Its family tree reaches back 2 generations to 1995. 1 of the 211 devices in its family, counting itself, has a Class I recall. 208 later devices descend from it.
- Decided
- May 26, 2000
- Review
- 156 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945188 (1995). 208 later devices descend from it, 2 citing it directly. 1 of the 211 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 1 generation backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- This deviceK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- Descendant · cites it directly · 207 of its ownK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- Descendant · 2 generations on · 134 of its ownK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- Descendant · 3 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 4 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · 5 generations on · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
Showing 5 of 208 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 208 · See all- K012086Aquariusnet ServerTerarecon,Inc. · 2001 · cites it directly207descendants
- K061214Aquariusaps ServerTerarecon,Inc. · 2006 · 2 generations on134descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 3 generations on99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 4 generations on63descendants
- K150843syngo®.via (version VB10A)Siemens AG · 2015 · 5 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −1 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| 0 (this device) | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| +1 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| +2 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| +3 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +4 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +5 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 9 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 12 | 0 |
| 2019 | 10 | 0 |
| 2020 | 21 | 0 |
| 2021 | 10 | 0 |
| 2022 | 15 | 0 |
| 2023 | 17 | 0 |
| 2024 | 21 | 0 |
| 2025 | 22 | 1 |
| 2026 | 17 | 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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K961023 | Aidp (Accuimage Image Display Processor)Summary page 1…e of Federal Regulations, § 892.2020 & § 892.2050. Now proposed exempt, final rule pending. ProCode: 90-LMD & 90-LLZ Equivalent Device(s): Acculmage™ Viewer Products, K961023, by Acculmage, Inc. The referenced systems are equivalent to the DiVS and IiVS™ Integrated image Viewing Stations in terms of ba… | 1996 |
What descends from it? (208)
See all 2082 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K012086 (Terarecon,Inc., 2001) has gone furthest, with 207 descendants of its own.
- 9 other devices also cite its predicate K961023.
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?
Acquire, store, transmit, and display medical images and patient reports of various types. Teleradiology image acquisition, distribution, archive and viewing.
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/K994329 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994329: Iivs Integrated Image Viewing Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994329
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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