Chrysalis Intelligence · Sponsors · Philips Image Guided Therapy Corporation

Philips Image Guided Therapy Corporation

San Diego, CA, US · 4 510(k) clearances · 11 PMAs

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Total clearances
4
2020-05-22 → 2026-02-24
Last 12 months
1
Product codes
2
Most recent
2026-02-24
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OBJ Catheter, Ultrasound, Intravascular Class II Cardiovascular 3 2025-05-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Class II Radiology 1 2026-02-24
Class III

PMA approvals (11)

Total PMA records
11
Originals + supplements
Distinct product codes
2
First decision
2020-01-28
Most recent
2026-02-12
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-02-12 P230021-S003 Duo Venous Stent System Normal 180 Day Track No User Fee QAN Stent, Iliac Vein Unknown
2025-11-18 P230021-S002 Duo Venous Stent System Normal 180 Day Track No User Fee QAN Stent, Iliac Vein Unknown
2025-02-11 P230021-S001 Duo Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2023-12-26 P230021 Duo Venous Stent System Original QAN Stent, Iliac Vein Unknown
2022-09-29 P180034-S006 Tack Endovascular System (6F) 135 Review Track For 30-Day Notice QCT — —
2022-05-24 P180034-S007 Tack Endovascular System (6F) Normal 180 Day Track QCT — —
2021-09-07 P180034-S005 Tack Endovascular System (6F) Normal 180 Day Track No User Fee QCT — —
2021-03-16 P180034-S004 Tack Endovascular System 30-Day Notice QCT — —
2020-09-28 P180034-S003 Tack Endovascular System (6F) 30-Day Notice QCT — —
2020-04-15 P180034-S002 Tack Endovascular System (6F) 30-Day Notice QCT — —
2020-01-28 P180034-S001 Tack Endovascular System (6F) Normal 180 Day Track QCT — —
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2026-02-24 K253714 IntraSight Plus IYO Class II Radiology
2025-05-09 K251103 VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) OBJ Class II Cardiovascular
2020-09-02 K200812 VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter OBJ Class II Cardiovascular
2020-05-22 K200410 Reconnaissance PV .018 OTW Digital IVUS Catheter OBJ Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence