510(k) · Cleared
Recalled · 2003Icon Computer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Gammasonics, Inc. · JWM System, Tomographic, Nuclear
Cleared on Nov 22, 1991 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 420 devices in its family, counting itself, has a Class I recall. 419 later devices descend from it. It has been recalled once.
- Decided
- Nov 22, 1991
- Review
- 56 days
- Class
- Class II
- Product code
- JWM
- Recalls
- 1
- Predicates
- 0
419 later devices descend from it, 3 citing it directly. 1 of the 420 devices in this family, counting this one, has a Class I recall.
- This deviceK914350 Icon Computer SystemSiemens Gammasonics, Inc. · 1991
- Descendant · cites it directly · 413 of its ownK972886 MirageSegami Corp., Inc. · 1997
- Descendant · 2 generations on · 382 of its ownK041022 Neuroq - Pet DPSyntermed, Inc. · 2004
- Descendant · 3 generations on · 380 of its ownK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- Descendant · 3 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 4 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
Showing 5 of 419 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025
Most influential descendants
Showing 5 of 419 · See all- K972886MirageSegami Corp., Inc. · 1997 · cites it directly413descendants
- K041022Neuroq - Pet DPSyntermed, Inc. · 2004 · 2 generations on382descendants
- K042863SceniumSiemens Molecular Imaging, Ltd. · 2004 · 3 generations on380descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 3 generations on350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 4 generations on287descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914350 | Icon Computer System | Siemens Gammasonics, Inc. | 1991 | — |
| +1 | K972886 | Mirage | Segami Corp., Inc. | 1997 | — |
| +2 | K041022 | Neuroq - Pet DP | Syntermed, Inc. | 2004 | — |
| +3 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| +3 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +4 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 3 | 0 |
| 2010 | 9 | 0 |
| 2011 | 9 | 0 |
| 2012 | 10 | 0 |
| 2013 | 9 | 0 |
| 2014 | 14 | 0 |
| 2015 | 13 | 0 |
| 2016 | 18 | 0 |
| 2017 | 18 | 0 |
| 2018 | 28 | 0 |
| 2019 | 24 | 0 |
| 2020 | 32 | 0 |
| 2021 | 27 | 0 |
| 2022 | 32 | 0 |
| 2023 | 34 | 0 |
| 2024 | 30 | 0 |
| 2025 | 42 | 1 |
| 2026 | 38 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (419)
See all 4193 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 10, 2003 | Not classified | Z-0727-03 | Other | ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions. |
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 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K972886 (Segami Corp., Inc., 1997) has gone furthest, with 413 descendants of its own.
How does its category compare?
All JWM devicesJWM System, Tomographic, Nuclear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWM
FDA has decided no JWM device since 2007.
Median 510(k) review, days · JWM
Too few JWM 510(k)s in any year since 2007 to give a median.
Recalls per year · JWM
No recall names JWM since 2007.
Adverse event reports per year · JWM
No MAUDE report names JWM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K914350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914350: Icon Computer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914350
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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