Optima
Optima IGS 320 001 UDI
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Ge Hualun Medical Systems Co., Ltd., China |
|---|---|
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| 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 320 001 | 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 |
|---|---|
| K172700 | 2017-11-09 |
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.