510(k) · Cleared
ClearedImageview Coronary Angiography Display and Review System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartware, Inc. · IZI System, X-Ray, Angiographic
Cleared on Oct 16, 1997 as substantially equivalent to K954479 (Heartlab, Inc., 1996) and 1 other predicate after a 125-day review. Its family tree reaches back 1 generation to 1996. 143 later devices descend from it.
- Decided
- Oct 16, 1997
- Review
- 125 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954479 (1996). 2 ancestors in all. 143 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK954479 DicomviewHeartlab, Inc. · 1996
- This deviceK972229 Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 1997
- Descendant · cites it directly · 142 of its ownK994210 Inturis SuitePhilips Medical Systems, Inc. · 2000
- Descendant · 2 generations on · 129 of its ownK022788 Philips Harmony Release 1Philips Medical Systems North America Co. · 2002 · Recalled
- Descendant · 3 generations on · 128 of its ownK061995 XceleraPhilips Medical Systems North America Co. · 2006
- Descendant · 4 generations on · 89 of its ownK083348 Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008
- Descendant · 5 generations on · 86 of its ownK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
Showing 5 of 143 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 143 · See all- K994210Inturis SuitePhilips Medical Systems, Inc. · 2000 · cites it directly142descendants
- K022788Philips Harmony Release 1Philips Medical Systems North America Co. · 2002 · 2 generations on129descendants
- K061995XceleraPhilips Medical Systems North America Co. · 2006 · 3 generations on128descendants
- K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008 · 4 generations on89descendants
- K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH · 2009 · 5 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954479 | Dicomview | Heartlab, Inc. | 1996 | — |
| 0 (this device) | K972229 | Imageview Coronary Angiography Display and Review System | Heartware, Inc. | 1997 | — |
| +1 | K994210 | Inturis Suite | Philips Medical Systems, Inc. | 2000 | — |
| +2 | K022788 | Philips Harmony Release 1 | Philips Medical Systems North America Co. | 2002 | 2 |
| +3 | K061995 | Xcelera | Philips Medical Systems North America Co. | 2006 | — |
| +4 | K083348 | Image-Arena Applications | Tomtec Imaging Systems GmbH | 2008 | — |
| +5 | K090461 | Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 | Tomtec Imaging Systems GmbH | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (2)
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 |
|---|---|---|---|
| * | K954479 | DicomviewSummary page 1…lephone: Date Prepared: 2. Device Name Proprietary Name: Common Name: Classification Name: Classification Status: 3. Predicate Devices . DICOMview™ Heartlab, Inc. K954479 . Kodak Digital Jamieson Film K960043 Laurence A. Spero 919-471-6613 June 12, 1997 ImageView™ Coronary Angiography Display a… | 1996 |
| * | K960043 | Kodak Cardiology Digital Archive & Review SystemSummary page 1…Proprietary Name: Common Name: Classification Name: Classification Status: 3. Predicate Devices . DICOMview™ Heartlab, Inc. K954479 . Kodak Digital Jamieson Film K960043 Laurence A. Spero 919-471-6613 June 12, 1997 ImageView™ Coronary Angiography Display and Review System Cardiac Image Review S… | 1996 |
What descends from it? (143)
See all 1431 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994210 | Inturis Suite | 2000 | 142 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K994210 (Philips Medical Systems, Inc., 2000) has gone furthest, with 142 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 | — |
What is it indicated for?
The ImageView™ Coronary Angiography Display and Review System is a computer program which can be used to view the results of an X-ray cardiac angiography procedure on a personal computer workstation. The digital image record of the X-ray exposures made during a catheterization procedure can be retrieved from a compact disk (CD) and displayed on a computer workstation monitor. ImageView™ also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.
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/K972229 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972229: Imageview Coronary Angiography Display and Review System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972229
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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