510(k) · Cleared
ClearedThe TCS-Medcon's Telecardiology System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcon, Ltd. · IZI System, X-Ray, Angiographic
Cleared on Mar 23, 1998 as substantially equivalent to K964274 (Comview Corp., 1997) after a 98-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Mar 23, 1998
- Review
- 98 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942264 (1994). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK942264 DDR with Dpa and 30/60 Options (Digital Viewstation)Eigen Video · 1994
- 1 generation backK964274 Writestar, and ViewstarComview Corp. · 1997
- This deviceK974679 The TCS-Medcon's Telecardiology SystemMedcon, Ltd. · 1998
- Descendant · cites it directly · 3 of its ownK112720 Mckesson Horizon CardiologyMckesson Israel, Ltd. · 2012
- Descendant · 2 generations on · 2 of its ownK151850 McKesson CardiologyMckesson Israel, Ltd. · 2015
- Descendant · 3 generations on · 1 of its ownK181080 McKesson CardiologyChange Healthcare Israel, Ltd. · 2018
- Descendant · 4 generations on · 0 of its ownK212528 Change Healthcare CardiologyChange Healthcare Israel, Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K112720Mckesson Horizon CardiologyMckesson Israel, Ltd. · 2012 · cites it directly3descendants
- K151850McKesson CardiologyMckesson Israel, Ltd. · 2015 · 2 generations on2descendants
- K181080McKesson CardiologyChange Healthcare Israel, Ltd. · 2018 · 3 generations on1descendant
- K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942264 | DDR with Dpa and 30/60 Options (Digital Viewstation) | Eigen Video | 1994 | — |
| −1 | K964274 | Writestar, and Viewstar | Comview Corp. | 1997 | — |
| 0 (this device) | K974679 | The TCS-Medcon's Telecardiology System | Medcon, Ltd. | 1998 | — |
| +1 | K112720 | Mckesson Horizon Cardiology | Mckesson Israel, Ltd. | 2012 | — |
| +2 | K151850 | McKesson Cardiology | Mckesson Israel, Ltd. | 2015 | — |
| +3 | K181080 | McKesson Cardiology | Change Healthcare Israel, Ltd. | 2018 | — |
| +4 | K212528 | Change Healthcare Cardiology | Change Healthcare Israel, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 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.
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? (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 |
|---|---|---|---|
| * | K964274 | Writestar, and ViewstarSummary page 1…46, Israel 9 Tel: +972 3 648 7702 Kq 7L{ (P 7 Fax: +972 3 647 8593 Predicate Device(s) The TCS is substantially equivalent to ComView's WriteStar and ViewStar System (K964274). Name of the Device: The TCS - Medcon’s Telecardiology System Description of the Device: The TCS provides a complete software… | 1997 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112720 | Mckesson Horizon Cardiology | 2012 | 3 |
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K112720 (Mckesson Israel, Ltd., 2012) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K964274.
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 | — |
What is it indicated for?
TCS is a software device intended to acquire, print, archive and communicate catheterization laboratory image studies, and to view these images on a PC in real-time mode. In addition, the TCS is intended to provide image enhancement and filtering tools for the viewing of selected images, to import and generate DICOM CDs, to prepare reports in Microsoft® Word format and to export DICOM images into commercial file formats.
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/K974679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974679: The TCS-Medcon's Telecardiology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974679
Report an extraction error
Are you the manufacturer?
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