510(k) · Cleared
ClearedReconnaissance PV .018 OTW Digital IVUS Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Image Guided Therapy Corporation · OBJ Catheter, Ultrasound, Intravascular
Cleared on May 22, 2020 as substantially equivalent to K150442 (Volcano Corporation, 2015) and 1 other predicate after a 93-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it.
- Decided
- May 22, 2020
- Review
- 93 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K934139 (1995). 14 ancestors in all. 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 backK092596 Eagle Eye Platinum Digital Ivus CatheterVolcano Corporation · 2009
- 2 generations backK120697 Eagle Eye Platinum ST CatheterVolcano Corporation · 2012
- 1 generation backK143701 Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter…Volcano Corporation · 2015
- This deviceK200410 Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation · 2020
- Descendant · cites it directly · 0 of its ownK233948 Provisio™ SLT IVUS™ SystemProvisio Medical, Inc. · 2024
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 backK073473 Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus…Volcano Corporation · 2008
- 3 generations backK092596 Eagle Eye Platinum Digital Ivus CatheterVolcano Corporation · 2009
- 2 generations backK120697 Eagle Eye Platinum ST CatheterVolcano Corporation · 2012
- 1 generation backK143701 Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter…Volcano Corporation · 2015
- This deviceK200410 Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation · 2020
Most influential descendants
Showing 1 of 1 · See all- K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc. · 2024 · 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 | K073473 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging… | Volcano Corporation | 2008 | — |
| −3 | K092596 | Eagle Eye Platinum Digital Ivus Catheter | Volcano Corporation | 2009 | — |
| −2 | K120697 | Eagle Eye Platinum ST Catheter | Volcano Corporation | 2012 | — |
| −1 | K143701 | Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV… | Volcano Corporation | 2015 | — |
| 0 (this device) | K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | Philips Image Guided Therapy Corporation | 2020 | — |
| +1 | K233948 | Provisio™ SLT IVUS™ System | Provisio Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 OBJ? 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 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 |
|---|---|---|---|
| * | K150442 | Volcano Visions PV .018 Digital IVUS CatheterSummary page 4…21 CFR 892.1570 ITX: Diagnostic Ultrasound Transducer PREDICATE DEVICES: Visions PV .018 Digital IVUS Catheter (K150442) Visions EEP/EEP-ST/Visions PV .014P RX Digital IVUS Catheter (K1… | 2015 |
| * | K143701 | Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014…Summary page 4…ons PV .018 Digital IVUS Catheter (K150442) Visions EEP/EEP-ST/Visions PV .014P RX Digital IVUS Catheter (K143701) REFERENCE DEVICE: Visions PV .035 Digital IVUS Catheter (K153094) DEVICE DESCRIPTION: The Reconnaiss… | 2015 |
| † | K153094 | Visions PV .035 Digital IVUS Catheter | 2015 |
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 |
|---|---|---|---|
| K233948 | Provisio™ SLT IVUS™ System | 2024 | 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 25 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K233948 (Provisio Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K150442.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
The Reconnaissance PV .018 Digital IVUS catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicted for use in cerebral vessels.
The Reconnaissance PV .018 Digital IVUS catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200410: Reconnaissance PV .018 OTW Digital IVUS Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200410
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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