510(k) · Cleared
ClearedAcculupe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E For M Imaging Systems Div., Marquette Electronic · LMB Device, Digital Image Storage, Radiological
Cleared on Jan 24, 1996 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jan 24, 1996
- Review
- 72 days
- Class
- Class I
- Product code
- LMB
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK955184 AcculupeE For M Imaging Systems Div., Marquette Electronic · 1996
- Descendant · cites it directly · 6 of its ownK964274 Writestar, and ViewstarComview Corp. · 1997
- Descendant · 2 generations on · 4 of its ownK974679 The TCS-Medcon's Telecardiology SystemMedcon, Ltd. · 1998
- Descendant · 3 generations on · 3 of its ownK112720 Mckesson Horizon CardiologyMckesson Israel, Ltd. · 2012
- Descendant · 4 generations on · 2 of its ownK151850 McKesson CardiologyMckesson Israel, Ltd. · 2015
- Descendant · 5 generations on · 1 of its ownK181080 McKesson CardiologyChange Healthcare Israel, Ltd. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K964274Writestar, and ViewstarComview Corp. · 1997 · cites it directly6descendants
- K974679The TCS-Medcon's Telecardiology SystemMedcon, Ltd. · 1998 · 2 generations on4descendants
- K112720Mckesson Horizon CardiologyMckesson Israel, Ltd. · 2012 · 3 generations on3descendants
- K151850McKesson CardiologyMckesson Israel, Ltd. · 2015 · 4 generations on2descendants
- K181080McKesson CardiologyChange Healthcare Israel, Ltd. · 2018 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955184 | Acculupe | E For M Imaging Systems Div., Marquette Electronic | 1996 | — |
| +1 | K964274 | Writestar, and Viewstar | Comview Corp. | 1997 | — |
| +2 | K974679 | The TCS-Medcon's Telecardiology System | Medcon, Ltd. | 1998 | — |
| +3 | K112720 | Mckesson Horizon Cardiology | Mckesson Israel, Ltd. | 2012 | — |
| +4 | K151850 | McKesson Cardiology | Mckesson Israel, Ltd. | 2015 | — |
| +5 | K181080 | McKesson Cardiology | Change Healthcare Israel, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 LMB? 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 |
|---|---|---|---|
| K964274 | Writestar, and Viewstar | 1997 | 6 |
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, K964274 (Comview Corp., 1997) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LMB devicesLMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMB
FDA has decided no LMB device since 2007.
Median 510(k) review, days · LMB
Too few LMB 510(k)s in any year since 2007 to give a median.
Recalls per year · LMB
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMB
7in 2025
MAUDE reports naming product code LMB, 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 | — | 0 | 1 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 5 | 3 |
| 2010 | 0 | — | 0 | 16 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 1 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K955184 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955184: Acculupe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955184
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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