Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask— 510(k) K182079
Substantially EquivalentMedtec Inc. Dba Civco Medical Solutions
FDA 510(k) clearance K182079 for Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask, Substantially Equivalent on 2018-09-07. Applicant: Medtec Inc. Dba Civco Medical Solutions. Device class: 2.
Clearance details
- Applicant
- Medtec Inc. Dba Civco Medical Solutions
- 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 allMore clearances from Medtec Inc. Dba Civco Medical Solutions
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 →
Recalls naming K182079
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182079.
Data sourced from openFDA. This site is unofficial and independent of the FDA.