510(k) Report

FDA applicant

Philips Image Guided Therapy Corporation

San Diego, CA6 decisions2019–20262 recalls

FDA records 6 decisions for Philips Image Guided Therapy Corporation (San Diego, CA) from 2019 to 2026: 4 510(k) clearances and 2 original PMA approvals. Most are in product codes OBJ (Catheter, Ultrasound, Intravascular) and QCT (Scaffold, Dissection Repair). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Philips Image Guided Therapy Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12020: 22023: 12025: 12026 (partial year): 1
2019high 2 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2026

2025: 1, 1 Class I2026 (partial year): 1
2019high 1 (2025) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Philips Image Guided Therapy Corporation by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Philips Image Guided Therapy Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OBJCatheter, Ultrasound, Intravascular3decisions
  • QCTScaffold, Dissection Repair1decision
  • QANStent, Iliac Vein1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 93 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 135 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE CatheterPhilips Image Guided Therapy Corporation · 20201cites it
  • K200410Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation · 20201cites it

What has FDA decided for it lately?

  • K253714IntraSight PlusPhilips Image Guided Therapy Corporation · 20261 recall
  • K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography…Philips Image Guided Therapy Corporation · 2025
  • P230021Duo Venous Stent SystemPhilips Image Guided Therapy Corporation · 2023
  • K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE CatheterPhilips Image Guided Therapy Corporation · 2020
  • K200410Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation · 2020
  • P180034Tack Endovascular System (6F)Philips Image Guided Therapy Corporation · 20191 Class I recall

All 6 as Philips Image Guided Therapy Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K253714Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VAAug 6, 2026Class II
  • P180034Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack…Jan 10, 2025Class I