ZIEHM VISION 2
FDA 510(k) clearance K073346 · decided 2008-03-21
Clearance details
- K-number
- K073346
- Device name
- ZIEHM VISION 2
- Applicant
- Ziehm Imaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-11-29
- Decision date
- 2008-03-21
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Riverside, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ziehm Vision system, x-ray, tomography, computed. recall (Z-0575-2025) | Orthoscan, Inc. | 2024-12-02 |
| Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging recall (Z-0564-2014) | Ziehm Imaging Inc | 2013-12-24 |
| Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imagin recall (Z-0565-2014) | Ziehm Imaging Inc | 2013-12-24 |
| Double foot switch, type KF 2 1S/1 S-MED-AP, manufactured by the company Seute Schaltgerat recall (Z-1430-2012) | Ziehm Imaging Inc | 2012-04-16 |