IntraSight Plus— 510(k) K253714
Substantially EquivalentPhilips Image Guided Therapy Corporation
FDA 510(k) clearance K253714 for IntraSight Plus, Substantially Equivalent on 2026-02-24. Applicant: Philips Image Guided Therapy Corporation. Device class: 2.
Summary
Philips Image Guided Therapy Corporation's IntraSight Plus is filed under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 892.1560. The Cardiovascular review panel handled it as a Traditional 510(k), though the record lists Radiology as the classification panel.
Philips Image Guided Therapy filed from Colorado Springs, Colorado. FDA found it substantially equivalent 92 calendar days after receipt (November 24, 2025 to February 24, 2026).
Clearance details
- Applicant
- Philips Image Guided Therapy Corporation
- Product code
- Product code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Colorado Springs, CO, US
Recent devices under product code IYO
view allMore clearances from Philips Image Guided Therapy Corporation
view allAdverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K253714
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K253714.
Data sourced from openFDA. This site is unofficial and independent of the FDA.