Zenition 50
FDA 510(k) clearance K183101 · decided 2018-12-31
Clearance details
- K-number
- K183101
- Device name
- Zenition 50
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2018-11-07
- Decision date
- 2018-12-31
- Days to decision
- 54 days
- Clearance type
- Abbreviated
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Best Noord-Brabant, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system recall (Z-0241-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-23 |
| Zenition 50. Product Code 718096. The devices are used for radiological guidance and visua recall (Z-1580-2025) | Philips North America Llc | 2025-04-21 |
| Philips Zenition 50, Model Number: 718096 recall (Z-0352-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-11-12 |
| Zenition 50 & 70 Mobile Surgery C-arm recall (Z-0226-2024) | Philips North America | 2024-09-30 |