Ziehm Imaging Inc
FDA Regulatory Profile
Ziehm Imaging Inc appears in FDA public data with 14 recalls, 25 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1893-2017, Class II) was initiated on February 23, 2017. Its most recent 510(k) clearance was granted on March 17, 2025.
Summary
- Total Recalls
- 14
- 510(k) Clearances
- 25
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1893-2017 | Class II | Ziehm Imaging solo FD Mobile Fluoroscopic C-arm | February 23, 2017 |
| Z-2642-2016 | Class II | Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging | April 15, 2016 |
| Z-2644-2016 | Class II | Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging | April 15, 2016 |
| Z-2641-2016 | Class II | Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging | April 15, 2016 |
| Z-2640-2016 | Class II | Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging | April 15, 2016 |
| Z-2639-2016 | Class II | Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging | April 15, 2016 |
| Z-2643-2016 | Class II | Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging | April 15, 2016 |
| Z-0568-2014 | Class II | Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | November 21, 2013 |
| Z-0565-2014 | Class II | Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | November 21, 2013 |
| Z-0566-2014 | Class II | Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | November 21, 2013 |
| Z-0564-2014 | Class II | Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | November 21, 2013 |
| Z-0562-2014 | Class II | Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imagin | November 21, 2013 |
| Z-0567-2014 | Class II | Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | November 21, 2013 |
| Z-0563-2014 | Class II | Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | November 21, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243646 | Ziehm Solo FD | March 17, 2025 |
| K243735 | Ziehm Vision FD | March 13, 2025 |
| K243303 | Ziehm Vision RFD 3D | January 21, 2025 |
| K243328 | Ziehm Vision RFD | January 15, 2025 |
| K240099 | Ziehm Vision RFD | February 5, 2024 |
| K240020 | Ziehm Vision FD | January 30, 2024 |
| K234109 | Ziehm Solo FD | January 26, 2024 |
| K231700 | Ziehm Vision FD | December 15, 2023 |
| K231669 | Ziehm Solo FD | December 12, 2023 |
| K231692 | Ziehm Vision RFD | November 20, 2023 |
| K231701 | Ziehm Vision RFD 3D | July 10, 2023 |
| K203428 | Ziehm Vision RFD | March 17, 2021 |
| K202360 | Ziehm Vision RFD 3D | September 16, 2020 |
| K193230 | Ziehm Vision FD | December 20, 2019 |
| K190497 | Ziehm 8000 | November 20, 2019 |
| K161976 | Ziehm Solo FD | October 6, 2016 |
| K142740 | Ziehm Vision RFD 3D | April 6, 2015 |
| K132904 | ZIEHM VISION RFD | December 5, 2013 |
| K092438 | ZIEHM SOLO | December 23, 2009 |
| K083545 | ZIEHM VISION RFD | May 15, 2009 |