510(k) · Cleared
ClearedVideo Plus with Analytical Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camtronics, Ltd. · IZI System, X-Ray, Angiographic
Cleared on Aug 17, 1994 after a 114-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Aug 17, 1994
- Review
- 114 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 4 citing it directly.
- This deviceK941979 Video Plus with Analytical WorkstationCamtronics, Ltd. · 1994
- 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 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · 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) | K941979 | Video Plus with Analytical Workstation | Camtronics, Ltd. | 1994 | — |
| +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 |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 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 IZI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (11)
See all 114 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?
- Of its descendants, K964274 (Comview Corp., 1997) has gone furthest, with 6 descendants of its own.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K941979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941979: Video Plus with Analytical Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941979
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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