510(k) · Cleared
ClearedX-Ray Angiographic System
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 Dec 13, 1993 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 13, 1993
- Review
- 89 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK934496 X-Ray Angiographic SystemCamtronics, Ltd. · 1993
- Descendant · cites it directly · 2 of its ownK974315 Vidar VXR LS Laser Film DigitizerVidar Systems Corp. · 1998
- Descendant · cites it directly · 1 of its ownK955519 Analytical Review StationCamtronics, Ltd. · 1996 · Recalled
- Descendant · 2 generations on · 0 of its ownK992073 AX WorkstationSiemens Medical Solutions USA, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK992112 Samsung Raypax Film DigitizerSamsung Sds Co., Ltd. · 1999
- Descendant · 2 generations on · 0 of its ownK984409 Elk Laser Film DigitizerNishimoto Sangyo Co., Ltd. · 1999
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K974315Vidar VXR LS Laser Film DigitizerVidar Systems Corp. · 1998 · cites it directly2descendants
- K955519Analytical Review StationCamtronics, Ltd. · 1996 · cites it directly1descendant
- K992073AX WorkstationSiemens Medical Solutions USA, Inc. · 1999 · 2 generations on0descendants
- K992112Samsung Raypax Film DigitizerSamsung Sds Co., Ltd. · 1999 · 2 generations on0descendants
- K984409Elk Laser Film DigitizerNishimoto Sangyo Co., Ltd. · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934496 | X-Ray Angiographic System | Camtronics, Ltd. | 1993 | — |
| +1 | K974315 | Vidar VXR LS Laser Film Digitizer | Vidar Systems Corp. | 1998 | — |
| +1 | K955519 | Analytical Review Station | Camtronics, Ltd. | 1996 | 1 |
| +2 | K992073 | AX Workstation | Siemens Medical Solutions USA, Inc. | 1999 | — |
| +2 | K992112 | Samsung Raypax Film Digitizer | Samsung Sds Co., Ltd. | 1999 | — |
| +2 | K984409 | Elk Laser Film Digitizer | Nishimoto Sangyo Co., Ltd. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 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? (6)
3 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, K974315 (Vidar Systems Corp., 1998) has gone furthest, with 2 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/K934496 · printed Nov 4, 2026
Cite this page
510(k) Report. “K934496: X-Ray Angiographic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934496
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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