Ziehm Imaging GmbH
Orlando, FL, US
ZIEHM IMAGING GMBH appears in FDA device records in Orlando, FL. FDA records list 25 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 15 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 25 510(k) clearances for Ziehm Imaging GmbH between 2005 and 2025. The busiest year on record is 2023, with 4. The most recent is 2025, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 3 |
| 2008 | 1 |
| 2009 | 2 |
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 4 |
| 2024 | 3 |
| 2025 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243646 | Ziehm Solo FD | OWB | Substantially Equivalent | |
| K243735 | Ziehm Vision FD | OWB | Substantially Equivalent | |
| K243303 | Ziehm Vision RFD 3D | OWB | Substantially Equivalent | |
| K243328 | Ziehm Vision RFD | OWB | Substantially Equivalent | |
| K240099 | Ziehm Vision RFD | OWB | Substantially Equivalent | |
| K240020 | Ziehm Vision FD | OWB | Substantially Equivalent | |
| K234109 | Ziehm Solo FD | OWB | Substantially Equivalent | |
| K231700 | Ziehm Vision FD | OWB | Substantially Equivalent | |
| K231669 | Ziehm Solo FD | OWB | Substantially Equivalent | |
| K231692 | Ziehm Vision RFD | OWB | Substantially Equivalent | |
| K231701 | Ziehm Vision RFD 3D | OWB | Substantially Equivalent | |
| K203428 | Ziehm Vision RFD | JAA | Substantially Equivalent | |
| K202360 | Ziehm Vision RFD 3D | OWB | Substantially Equivalent | |
| K193230 | Ziehm Vision FD | OWB | Substantially Equivalent | |
| K190497 | Ziehm 8000 | OWB | Substantially Equivalent | |
| K161976 | Ziehm Solo FD | OWB | Substantially Equivalent | |
| K142740 | Ziehm Vision RFD 3D | OWB | Substantially Equivalent | |
| K132904 | ZIEHM VISION RFD | JAA | Substantially Equivalent | |
| K092438 | ZIEHM SOLO | OWB | Substantially Equivalent | |
| K083545 | ZIEHM VISION RFD | OWB | Substantially Equivalent | |
| K073346 | ZIEHM VISION 2 | JAK | Substantially Equivalent | |
| K061534 | ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM | OWB | Substantially Equivalent | |
| K061310 | ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM | JAK | Substantially Equivalent | |
| K061203 | ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM | OWB | Substantially Equivalent | |
| K051064 | ZIEHM QUANTUM | OWB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9681146 | 3005430103 | ZIEHM IMAGING GMBH | Lina-Ammon-Strasse 10, NUERNBERG, BAVARIA 90471 DE | 2026 | |
| 2027299 | 2027299 | Ziehm Imaging Inc. | 6280 Hazeltine National Dr Ste 100, Orlando, FL 32822 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1893-2017 | Ziehm Imaging solo FD Mobile Fluoroscopic C-arm | During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component | Class II | Terminated | |
| Z-2644-2016 | Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging | Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted. | Class II | Terminated | |
| Z-2643-2016 | Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging | Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted. | Class II | Terminated | |
| Z-2642-2016 | Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging | Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted. | Class II | Terminated | |
| Z-2641-2016 | Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging | Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted. | Class II | Terminated | |
| Z-2640-2016 | Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging | Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted. | Class II | Terminated | |
| Z-2639-2016 | Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging | Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted. | Class II | Terminated | |
| Z-0568-2014 | Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. | Class II | Terminated | |
| Z-0567-2014 | Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. | Class II | Terminated | |
| Z-0566-2014 | Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. | Class II | Terminated | |
| Z-0565-2014 | Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. | Class II | Terminated | |
| Z-0564-2014 | Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. | Class II | Terminated | |
| Z-0563-2014 | Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. | Class II | Terminated | |
| Z-0562-2014 | Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. | Class II | Terminated | |
| Z-1430-2012 | Double foot switch, type KF 2 1S/1 S-MED-AP, manufactured by the company Seute Schaltgerate. GmbH & Co. KG for Ziehm Imaging GmbH Germany, and used with Ziehm Imaging GmbH Mobile C-arm as a component thereof. Two versions were made: 2 pedal version KF 2 1S/1 S-MED-AP foot switch and 4 pedal foot switch version KF 2 1S/1 S-MED-AP This type of foot switch includes a pair of the dual foot switches assembled on a single metal bracket. The following labels may appear on the foot switch: Labeled in part: "Fluoro- Store***ZIN Part no. # 58371***ZIR Part no. # 10-2985*** Left Pedal: Initiate Radiation***Right Pedal: Store Image***" Labeled in part: "Fluoro - Cine***ZIN Part no. # 58415***ZIR Part no. # 10-2987*** Left Pedal: Initiate Radiation***Right Pedal: Switch into Cine mode***" Labeled in part: "Fluoro - Mag***ZIN Part no. # 58413***ZIR Part no. # 10-2989*** Left Pedal: Initiate Radiation***Right Pedal: Switch through magnification***" Labeled in part: "Fluoro -Snap***ZIN Part no. # 58417***ZIR Part no. # 10-2991*** Left Pedal: Initiate Radiation ***Right Pedal: Initiate Snapshot***" Labeled in part: "DSA - CINE***ZIN Part no. # 58419***ZIR Part no. # 10-2993*** Left Pedal: Switch into DSA mode ***Right Pedal: Switch into Cine mode***" Labeled in part: "Cine - Store***ZIN Part no. # 58421***ZIR Part no. # 10-2995*** Left Pedal: Switch into Cine mode***Right Pedal: Store Image***" Labeled in part: "Cine - LONG:Endo ON/OFF & SHORT:Freeze*** ZIN Part no. # 58423***ZIR Part no. # 10-2997*** Left Pedal: Switch into Cine mode***Right Pedal: Long: Switch Endo On/Off Short: Freeze the endoscopic image on live screen***" Labeled in part: "Cine- Endo ON /OFF***ZIN Part no. # 58425***ZIR Part no. # 10-2999*** Left Pedal: Switch into Cine mode***Right Pedal: Switch Endo On / Off***" Labeled in part: "Fluoro - Swap***ZIN Part no. # 58427***ZIR Part no. # 10-3031*** Left Pedal: Initiate Radiation***Right Pedal: Swaps the image between the live and reference screens***" Labeled in part: "DSA / MSA/RSA - OFF***ZIN Part no. #58429***ZIR Part no. #10-3033***Left Pedal: Switch DSA/MSA/RSA On***Right Pedal: Switch DSA/MSA/RSA Off***" The KF 2 1S/1S-MED- AP foot switch is a component of the Mobile C-arm and is used by the physician to activate Fluoroscopic X-Ray for imaging by pressing the foot switch. | On 04/29/2011, Ziehm Imaging, Inc., Orlando, FL recalled the double foot switch, type KF 2 1S/1S-MED-AP, a component used with Ziehm Imaging GmbH Mobile C-arm due to the potential of unintentional continued activation of fluoroscopic X-ray as the foot switch may not become inactive when the pedal is released. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain