510(k) · Cleared
ClearedPreview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000; Pimf Model 87-Pimf; Laptop System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Corporation · DQY Catheter, Percutaneous
Cleared on Apr 24, 2013 as substantially equivalent to K080891 (Volcano Corporation, 2008) and 2 other predicates after a 222-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it.
- Decided
- Apr 24, 2013
- Review
- 222 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K934139 (1995). 49 ancestors in all, the oldest K823434 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 5 generations between
- 3 generations backK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- 2 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 1 generation backK113486 Volcano S5I Intravascular Ultracound Imaging and Pressure SystemVolcano Corporation · 2012
- This deviceK122826 Preview Forward-Looking Ivus Catheter and Laptop System; Preview…Volcano Corporation · 2013
- Descendant · cites it directly · 0 of its ownK132659 Volcano Preview Forward-Looking Ivus SystemVolcano Corporation · 2013
Show all 9 generations
- Root · 9 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 8 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 7 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 6 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 5 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 4 generations backK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- 3 generations backK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- 2 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 1 generation backK113486 Volcano S5I Intravascular Ultracound Imaging and Pressure SystemVolcano Corporation · 2012
- This deviceK122826 Preview Forward-Looking Ivus Catheter and Laptop System; Preview…Volcano Corporation · 2013
Most influential descendants
Showing 1 of 1 · See all- K132659Volcano Preview Forward-Looking Ivus SystemVolcano Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −8 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −7 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −6 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −5 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −4 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| −3 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| −2 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| −1 | K113486 | Volcano S5I Intravascular Ultracound Imaging and Pressure System | Volcano Corporation | 2012 | — |
| 0 (this device) | K122826 | Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter… | Volcano Corporation | 2013 | — |
| +1 | K132659 | Volcano Preview Forward-Looking Ivus System | Volcano Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K080891 | Revolution 45MHZ Ivus Imaging CatheterSummary page 1…CFR Part 870.1250 Class II Device PREDICATE DEVICE: Volcano Revolutionlo Catheter (K080891) Volcano s5/s5i Imaging System (Ki 13486)… | 2008 |
| * | K113486 | Volcano S5I Intravascular Ultracound Imaging and Pressure System | 2012 |
| * | K111704 | Avinger Wildcat 6F Guidewire Support Catheter and Juicebox | 2011 |
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 |
|---|---|---|---|
| K132659 | Volcano Preview Forward-Looking Ivus System | 2013 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 49 ancestors have a recall of any class.
- Of its descendants, K132659 (Volcano Corporation, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K080891.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The PreView® Forward-Looking IVUS Catheter and Laptop System is indicated for use to facilitate the intraluminal placement of guidewires in the peripheral vasculature prior to further percutaneous intervention and to support guidewires in accessing discrete regions of the peripheral vasculature, to assess vessel morphology, assess the position of the catheter tip within the vessel lumen, and to facilitate placement and exchanges of guidewires and other…
Read the full statement (133 words)
The PreView® Forward-Looking IVUS Catheter and Laptop System is indicated for use to facilitate the intraluminal placement of guidewires in the peripheral vasculature prior to further percutaneous intervention and to support guidewires in accessing discrete regions of the peripheral vasculature, to assess vessel morphology, assess the position of the catheter tip within the vessel lumen, and to facilitate placement and exchanges of guidewires and other interventional devices compatible with 0.014" guidewire lumens. The Preview® Forward-Looking IVUS Catheter is designed as an adjunct to conventional angiographic procedures to provide a forward-looking image of the vessel lumen and wall structures.
The PreView® Forward-Looking IVUS Catheter and Laptop System is not indicated for use for imaging with the exposed rotating tip inside a stent. This device is not indicated for use in coronary or cerebral vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122826: Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000; Pimf Model 87-Pimf; Laptop System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122826
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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