IntraSight Plus
FDA 510(k) clearance K253714 · decided 2026-02-24
Clearance details
- K-number
- K253714
- Device name
- IntraSight Plus
- Applicant
- Philips Image Guided Therapy Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-11-24
- Decision date
- 2026-02-24
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- IYO
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Colorado Springs, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Duo Venous Stent System (P230021/S002) | Philips Image Guided Therapy Corporation | 2025-11-18 |
| Duo Venous Stent System (P230021/S001) | Philips Image Guided Therapy Corporation | 2025-02-11 |
| Duo Venous Stent System (P230021) | Philips Image Guided Therapy Corporation | 2023-12-26 |
| Tack Endovascular System (6F) (P180034/S006) | Philips Image Guided Therapy Corporation | 2022-09-29 |
| Tack Endovascular System (6F) (P180034/S007) | Philips Image Guided Therapy Corporation | 2022-05-24 |
| Tack Endovascular System (6F) (P180034/S005) | Philips Image Guided Therapy Corporation | 2021-09-07 |
| Tack Endovascular System (P180034/S004) | Philips Image Guided Therapy Corporation | 2021-03-16 |
| Tack Endovascular System (6F) (P180034/S003) | Philips Image Guided Therapy Corporation | 2020-09-28 |