Philips Image Guided Therapy Corporation: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Philips Image Guided Therapy Corporation” (first 2020, latest 2026), plus 2 PMA decisions, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 92 days. Since 2017 the median was 92 days, against 96 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Philips, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 2 | 126 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 28 |
| 2026 | 1 | 92 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Philips Image Guided Therapy Corporation took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OBJ | Catheter, Ultrasound, Intravascular | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| QAN | Stent, Iliac Vein | 1 | 0 |
| QCT | Scaffold, Dissection Repair | 1 | 0 |
Review panels
- Cardiovascular (5)
- Radiology (1)
Most recent Philips Image Guided Therapy Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253714 | IntraSight Plus | IYO | 2026-02-24 | 92 |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) | OBJ | 2025-05-09 | 28 |
| K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter | OBJ | 2020-09-02 | 159 |
| K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | OBJ | 2020-05-22 | 93 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230021 | PMA | Duo Venous Stent System | 2023-12-26 |
| P180034 | PMA | Tack Endovascular System (6F) | 2019-04-11 |
Recalls
openFDA lists no recalls under a recalling firm named Philips Image Guided Therapy Corporation.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Philips Medical Systems, Inc. (218 510(k)s)
- Philips Medical Systems (Cleveland), Inc. (190 510(k)s)
- Philips Medical Systems Nederland B.V. (106 510(k)s)
- Philips Medical Systems North America, Inc. (95 510(k)s)
- Philips Ultrasound, Inc. (51 510(k)s)
- Philips Medizin Systeme Boeblingen GmbH (48 510(k)s)
- Philips Ultrasound, LLC (26 510(k)s)
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (25 510(k)s)
- Philips Medizin Systeme Boblingen GmbH (22 510(k)s)
- Philips Health Care (20 510(k)s)
- Philips Hearing Instruments Co. (20 510(k)s)
- Philips Medical Systems Dmc GmbH (18 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Philips Image Guided Therapy Corporation?
FDA lists 4 510(k) clearances under the applicant name “Philips Image Guided Therapy Corporation” (first 2020, latest 2026), plus 2 PMA decisions, across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Philips Image Guided Therapy Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Image Guided Therapy Corporation is 92 days. Since 2017: 92 days, versus 96 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Philips Image Guided Therapy Corporation?
The most frequent FDA product codes under this applicant name are OBJ (Catheter, Ultrasound, Intravascular, 3); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1); QAN (Stent, Iliac Vein, 1).
Next steps
- See all 4 Philips Image Guided Therapy Corporation clearances with predicates and recalls
- Run predicate analysis for product code OBJ, Philips Image Guided Therapy Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.