FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
ImagingRing System on Rails
K Number: K191267
·
Decision Aug 1, 2019
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
4
Review Days
83
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Basic Information
- Device Name
- ImagingRing System on Rails
- K Number
- K191267
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medphoton GmbH
- Date Received
- May 10, 2019
- Decision Date
- August 1, 2019
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by Medphoton GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K234067 | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | Mar 28, 2025 | Substantially Equivalent |
| K203281 | Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X | Dec 22, 2020 | Substantially Equivalent |
| K161400 | ImagingRing System | Dec 8, 2016 | Substantially Equivalent |