INTERA I/T
FDA 510(k) clearance K013344 · decided 2001-12-11
Clearance details
- K-number
- K013344
- Device name
- INTERA I/T
- Applicant
- Philips Medical Systems North America Co.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-09
- Decision date
- 2001-12-11
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System recall (Z-0885-2019) | Philips Medical Systems Nederlands | 2019-02-22 |
| SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T recall (Z-1024-2016) | Philips Electronics North America Corporation | 2016-02-26 |