FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
K Number: K234067
·
Decision Mar 28, 2025
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
4
Review Days
462
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Basic Information
- Device Name
- ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
- K Number
- K234067
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medphoton GmbH
- Date Received
- December 22, 2023
- Decision Date
- March 28, 2025
- Product Code
- OWB
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
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