Ziehm 8000
The Ziehm 8000 is a mobile C-arm X-ray system used to provide fluoroscopic images during diagnostic, interventional and surgical procedures. It can be used inside or outside the operating…
The Ziehm 8000 is a mobile C-arm X-ray system used to provide fluoroscopic images during diagnostic, interventional and surgical procedures. It can be used inside or outside the operating room for procedures requiring X-ray guidance, including orthopaedic, vascular, urological and emergency applications.
The system captures contactless X-ray images, displays them and stores them temporarily. Its imaging functions include digital subtraction and acquisition of cine loops, allowing the clinician to review sequences obtained during a procedure.
Patient and Imaging Scope
The system is intended for human patients of any age, with the physician deciding its use for infants and children. It does not support direct radiographic film exposure and is not intended for mammography.
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Ziehm Imaging Gmbh, Germany |
|---|---|
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Manufacturer |
| 510(k) | K190497 |
| Record published | 2020-03-12 |
| Record revised | 2025-03-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrackX | Trackx Technology Inc. | 86 |
| Trinias | Shimadzu Corp. | 54 |
| Allura Xper FD | Philips Medical Systems Nederland B.V. | 21 |
| Azurion | Philips Medical Systems Nederland B.V. | 19 |
| LessRay | Nuvasive, Inc. | 16 |
| Intelli-C Accessory | Nrt – Nordisk Røntgen Teknik A/S | 13 |
| Pulse | Nuvasive, Inc. | 12 |
| O-ARM® | Medtronic Navigation, Inc. | 11 |
| Genoray | Genoray Co., Ltd. | 10 |
| Fujifilm Healthcare Americas Corporation | A.T.S. Applicazione Tecnologie Speciali SRL | 7 |
| Fujifilm Medical Systems U.S.A. Inc. | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Stephanix | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243646 | 2025-03-17 |
| K243735 | 2025-03-13 |
| K243303 | 2025-01-21 |
| K243328 | 2025-01-15 |
| K240099 | 2024-02-05 |
| K240020 | 2024-01-30 |
| K234109 | 2024-01-26 |
| K231700 | 2023-12-15 |
| K231669 | 2023-12-12 |
| K231692 | 2023-11-20 |
| K231701 | 2023-07-10 |
| K202360 | 2020-09-16 |
| K193230 | 2019-12-20 |
| K190497 | 2019-11-20 |
| K161976 | 2016-10-06 |
| K142740 | 2015-04-06 |
| K092438 | 2009-12-23 |
| K083545 | 2009-05-15 |
| K061534 | 2006-07-07 |
| K061203 | 2006-06-19 |
| K051064 | 2005-05-26 |
Recalls
12 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-02-23 | Class II | Labeling design | 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 | US – 2 systems | 2019-12-11 |
| 2016-04-15 | Class II | Device Design | 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. | 1 device | 2019-07-18 |
| 2016-04-15 | Class II | Device Design | 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. | 31 devices | 2019-07-18 |
| 2016-04-15 | Class II | Device Design | 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. | 12 devices | 2019-07-18 |
| 2016-04-15 | Class II | Device Design | 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. | 2 devices | 2019-07-18 |
| 2013-11-21 | Class II | Device Design | 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. | 60 devices | 2014-06-23 |
| 2013-11-21 | Class II | Device Design | 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. | 1 device | 2014-06-23 |
| 2013-11-21 | Class II | Device Design | 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. | 83 devices | 2014-06-23 |
| 2013-11-21 | Class II | Device Design | 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. | 54 devices | 2014-06-23 |
| 2013-11-21 | Class II | Device Design | 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. | 103 devices | 2014-06-23 |
| 2013-11-21 | Class II | Device Design | 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. | 27 devices | 2014-06-23 |
| 2013-11-21 | Class II | Device Design | 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. | 58 devices | 2014-06-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.