K243081
- 510(k) number
- K243081
- Device name
- Green X 21 (PHT-90CHO)
- Applicant
- VATECH Co., Ltd. KR
- Product code
- OAS — X-Ray, Tomography, Computed, Dental
- Decision date
- 2025-02-14
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243081.pdf
Official FDA record: K243081
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.