FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IntraSight Plus
K Number: K253714
·
Decision Feb 24, 2026
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
4
Review Days
92
Basic Information
- Device Name
- IntraSight Plus
- K Number
- K253714
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Image Guided Therapy Corporation
- Date Received
- November 24, 2025
- Decision Date
- February 24, 2026
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Philips Image Guided Therapy Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) | May 9, 2025 | Substantially Equivalent |
| K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter | Sep 2, 2020 | Substantially Equivalent |
| K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | May 22, 2020 | Substantially Equivalent |