FDA 510(k)
FDA class 2
Substantially Equivalent
🇭🇺 Hungary
AnyScan 3.0 NM Scanner Family
K Number: K253844
·
Decision Dec 30, 2025
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
1
Review Days
28
Basic Information
- Device Name
- AnyScan 3.0 NM Scanner Family
- K Number
- K253844
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mediso Medical Imaging Systems, Ltd.
- Date Received
- December 2, 2025
- Decision Date
- December 30, 2025
- Product Code
- KPS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
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