Ziehm Vision FD
Catalogue number Vision FD, listed by Ziehm Imaging Gmbh, Germany, under Interventional Fluoroscopic X-Ray System. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
21510(k) clearances naming this product code
12recalls on this code
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 |
| Record published | 2020-03-12 |
| Record revised | 2024-12-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Vision FD | In distribution |
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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Orthoscan, Inc. | UDI-DI | 2024-08-08 | Class II | Radiation Control for Health and Safety Act | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when b | 22 |
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.