VERTIX 3D-U
FDA 510(k) clearance K802200 · decided 1980-10-23
Clearance details
- K-number
- K802200
- Device name
- VERTIX 3D-U
- Applicant
- Siemens Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-09-11
- Decision date
- 1980-10-23
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 3D TOP Ceiling Stand. X-Ray System model number 8773673 recall (Z-0335-06) | Siemens Medical Solutions USA, Inc | 2005-12-31 |