510(k) · Cleared
ClearedVeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)
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 9, 2025 as substantially equivalent to K200812 (Philips Image Guided Therapy Corporation, 2020) after a 28-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- May 9, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K071234 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK071234 Acunav Diagnostic Ultrasound Catheter 8F and 10FSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 2 generations backK170263 AcuNav Diagnostic Ultrasound Catheter 8F,10FSiemens Medical Solutions USA, Inc. · 2017
- 1 generation backK200812 VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight…Philips Image Guided Therapy Corporation · 2020
- This deviceK251103 VeriSight Intracardiac Echocardiography Catheter (VSICE2D)…Philips Image Guided Therapy Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10F | Siemens Medical Solutions USA, Inc. | 2007 | 1 |
| −2 | K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | Siemens Medical Solutions USA, Inc. | 2017 | — |
| −1 | K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE… | Philips Image Guided Therapy Corporation | 2020 | — |
| 0 (this device) | K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro… | Philips Image Guided Therapy Corporation | 2025 | — |
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? (1)
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 |
|---|---|---|---|
| * | K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE CatheterSummary page 5…er Description Regulation Number 870.1200 Product Code OBJ Device Class Class II Classification Panel Cardiovascular Predicate Device: K200812 – VeriSight/VeriSight Pro ICE Catheters Reference Device: K170263 AcuNav Diagnostic Ultrasound Catheter Subjec… | 2020 |
| † | K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 VeriSight/VeriSight Pro ICE catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
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/K251103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251103: VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251103
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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