Optima
Optima IGS 330 001 UDI
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Beijing (2), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| 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 |
| Careray Digital Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Ge Hualun Medical Systems Co., Ltd., China |
|---|---|
| FDA product code | JAA |
| Device type | System, X-Ray, Fluoroscopic, Image-Intensified |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| 510(k) | K122457 |
| Record published | 2016-08-01 |
| Record revised | 2025-04-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IGS 330 001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Preferred Medical Products, LLC | Preferred Medical Products, LLC | 324 |
| Unbranded | Advance Medical Designs, Inc. | 301 |
| N23 CCD System | Nical SPA | 57 |
| N33 CCD System | Nical SPA | 36 |
| Trinias | Shimadzu Corp. | 31 |
| Custom Cover | Advance Medical Designs, Inc. | 15 |
| Pulse | Nuvasive, Inc. | 15 |
| Sonialvision G4 | Shimadzu Corp. | 13 |
| LessRay | Nuvasive, Inc. | 13 |
| Micro Kover | Advance Medical Designs, Inc. | 11 |
| Stephanix | Stephanix | 10 |
| Snap Kover | Advance Medical Designs, Inc. | 9 |
Showing 12 of 169. All products under System, X-Ray, Fluoroscopic, Image-Intensified
Recalls Naming This Product
20 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2019-03-15 | Class II | Device Design | There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously. | 49 devices | |
| GE Medical Systems SCS | 510(k) number | 2018-03-29 | Class II | Process control | The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use. | 102 devices total | 2021-06-15 |
| GE Medical Systems SCS | 510(k) number | 2018-03-29 | Class II | Process control | The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use. | 102 devices total | 2021-06-15 |
| GE Medical Systems, LLC | 510(k) number | 2015-12-18 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor. | 2,111 (1078 US; 1033 OUS) | 2016-09-07 |
| GE Medical Systems, LLC | 510(k) number | 2015-11-13 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems. | 108 | 2016-09-07 |
| GE Medical Systems, LLC | 510(k) number | 2015-11-13 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems. | 45 | 2016-09-07 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 3 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 4 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 13 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 1 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 6 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 2 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 10 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 17 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 6 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 3 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 8 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 7 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2014-09-04 | Class II | Device Design | Loss of imaging – affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism. | 10 (4 US, 6 OUS). | 2015-01-21 |
| GE Medical Systems, LLC | 510(k) number | 2013-11-15 | Class II | Software design | GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the us | 28 (12 US, 16 OUS). | 2014-03-28 |
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.