Encompass SRS Headframe; Encompass MR SRS Headframe— 510(k) K182189
Substantially EquivalentQfix
FDA 510(k) clearance K182189 for Encompass SRS Headframe; Encompass MR SRS Headframe, Substantially Equivalent on 2018-10-04. Applicant: Qfix. Device class: 2.
Clearance details
- Device name as filed
- Encompass SRS Headframe ; Encompass MR SRS Headframe
- Applicant
- Qfix
- 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
- Special
- Location
- Avondale, PA, US
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Adverse 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.