K241963
- 510(k) number
- K241963
- Device name
- WERAY
- Applicant
- Picopack Co., Ltd. KR
- Product code
- EHD — Unit, X-Ray, Extraoral With Timer
- Decision date
- 2024-07-30
- Date received
- 2024-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K241963.pdf
Official FDA record: K241963
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.