Low Dose CT Lung Cancer Screening Option— 510(k) K180901
Substantially EquivalentHitachi Healthcare Americas
FDA 510(k) clearance K180901 for Low Dose CT Lung Cancer Screening Option, Substantially Equivalent on 2018-05-16. Applicant: Hitachi Healthcare Americas.
Clearance details
- Applicant
- Hitachi Healthcare Americas
- Product code
- Code JAK
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Twinsburg, OH, US
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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.