510(k) · Cleared
ClearedDicomview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartlab, Inc. · LMD System, Digital Image Communications, Radiological
Cleared on Feb 21, 1996 after a 148-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 144 later devices descend from it.
- Decided
- Feb 21, 1996
- Review
- 148 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 0
144 later devices descend from it, 1 citing it directly.
- This deviceK954479 DicomviewHeartlab, Inc. · 1996
- Descendant · cites it directly · 143 of its ownK972229 Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 1997
- Descendant · 2 generations on · 142 of its ownK994210 Inturis SuitePhilips Medical Systems, Inc. · 2000
- Descendant · 3 generations on · 129 of its ownK022788 Philips Harmony Release 1Philips Medical Systems North America Co. · 2002 · Recalled
- Descendant · 4 generations on · 128 of its ownK061995 XceleraPhilips Medical Systems North America Co. · 2006
- Descendant · 5 generations on · 89 of its ownK083348 Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008
Showing 5 of 144 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 144 · See all- K972229Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 1997 · cites it directly143descendants
- K994210Inturis SuitePhilips Medical Systems, Inc. · 2000 · 2 generations on142descendants
- K022788Philips Harmony Release 1Philips Medical Systems North America Co. · 2002 · 3 generations on129descendants
- K061995XceleraPhilips Medical Systems North America Co. · 2006 · 4 generations on128descendants
- K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008 · 5 generations on89descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954479 | Dicomview | Heartlab, Inc. | 1996 | — |
| +1 | K972229 | Imageview Coronary Angiography Display and Review System | Heartware, Inc. | 1997 | — |
| +2 | K994210 | Inturis Suite | Philips Medical Systems, Inc. | 2000 | — |
| +3 | K022788 | Philips Harmony Release 1 | Philips Medical Systems North America Co. | 2002 | 2 |
| +4 | K061995 | Xcelera | Philips Medical Systems North America Co. | 2006 | — |
| +5 | K083348 | Image-Arena Applications | Tomtec Imaging Systems GmbH | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 13 | 0 |
| 2021 | 8 | 0 |
| 2022 | 12 | 0 |
| 2023 | 12 | 0 |
| 2024 | 12 | 0 |
| 2025 | 23 | 0 |
| 2026 | 13 | 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? (144)
See all 1441 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972229 | Imageview Coronary Angiography Display and Review System | 1997 | 143 |
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?
- Of its descendants, K972229 (Heartware, Inc., 1997) has gone furthest, with 143 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/K954479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954479: Dicomview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954479
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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