Elekta Unity— 510(k) K223209
Substantially EquivalentElekta Solutions AB
FDA 510(k) clearance K223209 for Elekta Unity, Substantially Equivalent on 2023-02-23. Applicant: Elekta Solutions AB. Device class: 2.
Clearance details
- Applicant
- Elekta Solutions AB
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Recent devices under product code IYE
view allMore clearances from Elekta Solutions AB
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.