510(k) · Cleared
Recalled · 2005Analytical Review Station
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 May 9, 1996 as substantially equivalent to K941979 (Camtronics, Ltd., 1994) and 1 other predicate after a 157-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- May 9, 1996
- Review
- 157 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934496 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K992073AX WorkstationSiemens Medical Solutions USA, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934496 | X-Ray Angiographic System | Camtronics, Ltd. | 1993 | — |
| 0 (this device) | K955519 | Analytical Review Station | Camtronics, Ltd. | 1996 | — |
| +1 | K992073 | AX Workstation | Siemens Medical Solutions USA, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (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 |
|---|---|---|---|
| * | K941979 | Video Plus with Analytical WorkstationSummary page 1…ng Workstation Classification name: Medical Image Picture Archiving and Communications Device Predicate substantially equivalent devices: Camtronics Ltd. “Video Plus” (K941979), Camtronics Ltd. “Archium” (K934496) Device description: Digital image recording and display system for use in cardiac catheter… | 1994 |
| * | K934496 | X-Ray Angiographic SystemSummary page 1…Medical Image Picture Archiving and Communications Device Predicate substantially equivalent devices: Camtronics Ltd. “Video Plus” (K941979), Camtronics Ltd. “Archium” (K934496) Device description: Digital image recording and display system for use in cardiac catheterization, radiography/fluoroscopy, ult… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992073 | AX Workstation | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2005 | Not classified | Z-1421-05 | Other | The potential exists for the AI1000 workstation to mix images from one study with images from another study. Mixed studies could be from the same patient or from different patients. Mixed patient images could compromise patient condition… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
This product is intended primarily for on-line or _re_mgtg!l_qwmg of cardiac catheterization angiography studies communicated by network, or transported by CD-R interchage media. The CD-R media may also be used as a full resolution digital image archive of complete cath lab su.gi;sl to replace cine film. The ARS2 can optionally be used with other digital imaging modalities, such as R/F, nuclear-and ultrasound. The ARS?2 provides the capability to write and read CD-R optical discs which are produced in accordance w1th the ACC/NEMA DICOM standard.
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/K955519 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955519: Analytical Review Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955519
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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