Encompass SRS Headframe ; Encompass MR SRS Headframe— 510(k) K182189

Substantially Equivalent

Qfix

FDA 510(k) clearance K182189 for Encompass SRS Headframe ; Encompass MR SRS Headframe, Substantially Equivalent on 2018-10-04. Applicant: Qfix.

Clearance details

Applicant: Qfix
Product code: Code IYE
Advisory panel: Radiology
Date received: 2018-08-13
Decision date: 2018-10-04
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, 2020-01-01 through 2026-04-23. 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.