HF 718BD X-Ray System— 510(k) K160857
Substantially EquivalentArquilla, Inc. Dba X-Cel X-Ray Corporation
FDA 510(k) clearance K160857 for HF 718BD X-Ray System, Substantially Equivalent on 2017-02-24. Applicant: Arquilla, Inc. Dba X-Cel X-Ray Corporation.
Clearance details
- Applicant
- Arquilla, Inc. Dba X-Cel X-Ray Corporation
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crystal Lake, IL, US
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
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.