510(k) · Cleared
ClearedCAAS Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pie Medical Imaging BV · IZI System, X-Ray, Angiographic
Cleared on May 3, 2018 as substantially equivalent to K151780 (Pie Medical Imaging BV, 2016) and 1 other predicate after a 121-day review. Its family tree reaches back 14 generations to 1993. 1 of the 107 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- May 3, 2018
- Review
- 121 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K926514 (1993). 98 ancestors in all, the oldest K882061 (1988). 8 later devices descend from it, 3 citing it directly. 1 of the 107 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 10 generations between
- 3 generations backK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
- 2 generations backK133993 Caas WorkstationPie Medical Imaging · 2014
- 1 generation backK151780 CAAS WorkstationPie Medical Imaging BV · 2016
- This deviceK180019 CAAS WorkstationPie Medical Imaging BV · 2018
- Descendant · cites it directly · 4 of its ownK182611 Qangio XA 3DMedis Medical Imaging Systems BV · 2019
- Descendant · 2 generations on · 2 of its ownK210093 AccuFFRangioArteryFlow Technology Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK232147 CAAS WorkstationPie Medical Imaging BV · 2024
- Descendant · cites it directly · 0 of its ownK251355 X1-FFRSpectrawave, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243632 uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd. · 2025
Show all 14 generations
- Root · 14 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 13 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 12 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 11 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 10 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 9 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 8 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 7 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 6 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 5 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 4 generations backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- 3 generations backK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
- 2 generations backK133993 Caas WorkstationPie Medical Imaging · 2014
- 1 generation backK151780 CAAS WorkstationPie Medical Imaging BV · 2016
- This deviceK180019 CAAS WorkstationPie Medical Imaging BV · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…12 generations back · 2003
Most influential descendants
Showing 5 of 8 · See all- K182611Qangio XA 3DMedis Medical Imaging Systems BV · 2019 · cites it directly4descendants
- K210093AccuFFRangioArteryFlow Technology Co., Ltd. · 2021 · 2 generations on2descendants
- K232147CAAS WorkstationPie Medical Imaging BV · 2024 · cites it directly1descendant
- K251355X1-FFRSpectrawave, Inc. · 2025 · cites it directly0descendants
- K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −13 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −12 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −11 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −10 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −9 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −8 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −7 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −6 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −5 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −4 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| −3 | K100292 | Caas Qva 3D, Caas Qca 3D | Pie Medical Imaging BV | 2010 | — |
| −2 | K133993 | Caas Workstation | Pie Medical Imaging | 2014 | — |
| −1 | K151780 | CAAS Workstation | Pie Medical Imaging BV | 2016 | — |
| 0 (this device) | K180019 | CAAS Workstation | Pie Medical Imaging BV | 2018 | — |
| +1 | K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | 2019 | — |
| +2 | K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021 | — |
| +1 | K232147 | CAAS Workstation | Pie Medical Imaging BV | 2024 | — |
| +1 | K251355 | X1-FFR | Spectrawave, Inc. | 2025 | — |
| +2 | K243632 | uWS-Angio Basic | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 1 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K151780 | CAAS WorkstationSummary page 4…Classification Product Code: QHA Subsequent Product Code: LLZ Predicate Device CAAS Workstation (K151780, Angiographic X-ray System, 21 CFR 892.1600, IZI, LLZ) CAAS (K052988, Image Processing System, 21… | 2016 |
| * | K052988 | CAASSummary page 4…ct Code: LLZ Predicate Device CAAS Workstation (K151780, Angiographic X-ray System, 21 CFR 892.1600, IZI, LLZ) CAAS (K052988, Image Processing System, 21 CFR 892.2050, LLZ) Device Description The CAAS Workstation is designed as a stand-alone software p… | 2005 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 12 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 22 of the 98 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K182611 (Medis Medical Imaging Systems BV, 2019) has gone furthest, with 4 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. 2018, this device’s year, is highlighted.
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?
CAAS Workstation features segmentation of cardiovascular structures, 3D reconstruction of vessel segments and catheter path based on multiple angiographic images, measurement and reporting tools to facilitate the following use: • Calculate the dimensions of cardiovascular structures; • Quantify stenosis in coronary and peripheral vessels; • Quantify the motion of the left and right ventricular wall; • Perform density measurements; • Determine C-arm…
Read the full statement (111 words)
CAAS Workstation features segmentation of cardiovascular structures, 3D reconstruction of vessel segments and catheter path based on multiple angiographic images, measurement and reporting tools to facilitate the following use:
• Calculate the dimensions of cardiovascular structures;
• Quantify stenosis in coronary and peripheral vessels;
• Quantify the motion of the left and right ventricular wall;
• Perform density measurements;
• Determine C-arm position for optimal imaging of cardiovascular structures;
• Enhance stent visualization and measure stent dimensions;
• Quantify pressure drop in coronary vessels;
• Co-registration of angiographic X-Ray images with IVUS and OCT images.
CAAS Workstation is intended to be used by or under supervision of a cardiologist or radiologist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180019: CAAS Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180019
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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