Proton Positioing and Immobilization Devices— 510(k) K180021
Substantially EquivalentMedtec Inc Dba Civco Medical Solutions and Civco Radiotherap
FDA 510(k) clearance K180021 for Proton Positioing and Immobilization Devices, Substantially Equivalent on 2018-06-29. Applicant: Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap. Device class: 2.
Clearance details
- Applicant
- Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap
- 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
- Orange City, IA, US
Recent devices under product code IYE
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.