Elekta Unity
FDA 510(k) clearance K192482 · decided 2019-12-05
Clearance details
- K-number
- K192482
- Device name
- Elekta Unity
- Applicant
- Elekta Limited
- Decision
- Substantially Equivalent
- Date received
- 2019-09-10
- Decision date
- 2019-12-05
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Crawley, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7. recall (Z-2297-2020) | Elekta Limited | 2020-06-08 |
| Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: i recall (Z-2289-2020) | Elekta, Inc. | 2020-06-05 |