INTERA-SENSATION FAMILY
FDA 510(k) clearance K031815 · decided 2003-09-10
Clearance details
- K-number
- K031815
- Device name
- INTERA-SENSATION FAMILY
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2003-06-12
- Decision date
- 2003-09-10
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. Consi recall (Z-0794-2011) | Philips Medical Systems North America Co. Phillips | 2010-12-21 |
| The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and recall (Z-0469-2011) | Philips Medical Systems North America Co. Phillips | 2010-11-26 |
| Achieva MRI recall (Z-0983-2007) | Philips Medical Systems North America Co. Phillips | 2007-06-27 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
| HeartStart FRx Defibrillator (861304) (P180028/S016) | Philips Medical Systems | 2025-06-09 |
| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
| HeartStart FRx Defibrillator (861304) (P180028/S014) | Philips Medical Systems | 2024-02-21 |
| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |
| HeartStart FRx Defibrillator (861304) (P180028/S011) | Philips Medical Systems | 2021-11-15 |
| HeartStart FRx Defibrillator (861304) (P180028/S010) | Philips Medical Systems | 2021-09-24 |