FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ExamVue Apex
K Number: K244010
·
Decision Feb 24, 2025
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
418
Applicant Total
1
Review Days
60
Basic Information
- Device Name
- ExamVue Apex
- K Number
- K244010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JPI Healthcare Co, Ltd
- Date Received
- December 26, 2024
- Decision Date
- February 24, 2025
- Product Code
- MQB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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