K252174
- 510(k) number
- K252174
- Device name
- AquaCast Mask
- Applicant
- Blessing Cathay Corporation TW
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2025-09-03
- Date received
- 2025-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252174.pdf
Official FDA record: K252174
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.