PRACTIX CONVENIO
FDA 510(k) clearance K042368 · decided 2004-10-04
Clearance details
- K-number
- K042368
- Device name
- PRACTIX CONVENIO
- Applicant
- Philips Medical Systems North America Co.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-31
- Decision date
- 2004-10-04
- Days to decision
- 34 days
- Clearance type
- Abbreviated
- Product code
- IZL
- Device class
- 2
- Regulation number
- 892.1720
- 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 |
|---|---|---|
| Philips Practix Convenio Mobile X-ray System Model: 70455 The Practix Convenio is a mains recall (Z-1689-2012) | Philips Healthcare Inc. | 2012-05-30 |
| Practix 33 Mobile X-ray systems. The systems are used in general purpose diagnostic imagin recall (Z-0762-2007) | Philips Medical Systems North America Co. Phillips | 2007-09-25 |
| Practix 160 Mobile X-ray systems. The systems are used in general purpose diagnostic imagi recall (Z-0763-2007) | Philips Medical Systems North America Co. Phillips | 2007-09-25 |
| Practix 300 Mobile X-ray systems. The systems are used in general purpose diagnostic imagi recall (Z-0764-2007) | Philips Medical Systems North America Co. Phillips | 2007-09-25 |