K244010
- 510(k) number
- K244010
- Device name
- ExamVue Apex
- Applicant
- Jpi Healthcare Co, Ltd. KR
- Product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Decision date
- 2025-02-24
- Date received
- 2024-12-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K244010.pdf
Official FDA record: K244010
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.