FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Ziehm Vision RFD 3D
K Number: K202360
·
Decision Sep 16, 2020
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
18
Review Days
28
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Basic Information
- Device Name
- Ziehm Vision RFD 3D
- K Number
- K202360
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ziehm Imaging GmbH
- Date Received
- August 19, 2020
- Decision Date
- September 16, 2020
- 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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Other Clearances by Ziehm Imaging GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K243646 | Ziehm Solo FD | Mar 17, 2025 | Substantially Equivalent |
| K243735 | Ziehm Vision FD | Mar 13, 2025 | Substantially Equivalent |
| K243303 | Ziehm Vision RFD 3D | Jan 21, 2025 | Substantially Equivalent |
| K243328 | Ziehm Vision RFD | Jan 15, 2025 | Substantially Equivalent |
| K240099 | Ziehm Vision RFD | Feb 5, 2024 | Substantially Equivalent |
| K240020 | Ziehm Vision FD | Jan 30, 2024 | Substantially Equivalent |
| K234109 | Ziehm Solo FD | Jan 26, 2024 | Substantially Equivalent |
| K231700 | Ziehm Vision FD | Dec 15, 2023 | Substantially Equivalent |
| K231669 | Ziehm Solo FD | Dec 12, 2023 | Substantially Equivalent |
| K231692 | Ziehm Vision RFD | Nov 20, 2023 | Substantially Equivalent |