S5i Imaging System Workstation
Catalogue number 807401001, listed by Volcano Corporation, United States, under System, Imaging, Pulsed Echo, Ultrasonic. 37 manufacturers in China are registered for this product code.
37manufacturers in China registered for this device type
1catalogue number
19510(k) clearances naming this product code
16recalls on this code
Who Else Makes It
Concentrated in Guangdong (14), Jiangsu (9), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Raise Medical Industries, Inc. | Foshan | Guangdong | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Showing 12 of 37. All 37 manufacturers in China registered for System, Imaging, Pulsed Echo, Ultrasonic
Record
| Listed by | Volcano Corporation, United States |
|---|---|
| FDA product code | IYO |
| Device type | System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K071554 |
| Record published | 2016-09-12 |
| Record revised | 2021-10-26 (version 4) |
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 |
|---|---|---|
| 807401001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hitachi | Hitachi, Ltd. | 224 |
| eTRAX™ Needle | Civco Medical Instruments Co., Inc. | 43 |
| BladderScan® | Verathon Inc. | 38 |
| Verza Guidance System | Civco Medical Instruments Co., Inc. | 37 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 34 |
| Siui | Shantou Institute OF Ultrasonic Instruments Co., Ltd. | 34 |
| Biopsy Bracket | Civco Medical Instruments Co., Inc. | 33 |
| Tracking Bracket Starter Kit | Civco Medical Instruments Co., Inc. | 29 |
| System, Imaging, Pulsed Echo, Ultrasonic | GE Healthcare Japan Corporation | 23 |
| eTRAX™ Needle System Starter Kit | Civco Medical Instruments Co., Inc. | 20 |
| Tracking Bracket | Civco Medical Instruments Co., Inc. | 19 |
| Logiq | GE Ultrasound Korea, Ltd. | 18 |
Showing 12 of 805. All products under System, Imaging, Pulsed Echo, Ultrasonic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203719 | 2021-01-19 |
| K173860 | 2018-04-11 |
| K172455 | 2017-10-25 |
| K170385 | 2017-04-06 |
| K153369 | 2015-12-22 |
| K150441 | 2015-03-20 |
| K143122 | 2015-02-20 |
| K133323 | 2014-03-14 |
| K140291 | 2014-03-07 |
| K133641 | 2013-12-20 |
| K133142 | 2013-11-15 |
| K123898 | 2013-01-14 |
| K113486 | 2012-01-27 |
| K111706 | 2011-07-15 |
| K082229 | 2008-10-08 |
| K061215 | 2006-08-10 |
| K060483 | 2006-06-23 |
| K052348 | 2005-12-02 |
| K051920 | 2005-08-19 |
Recalls
12 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-01-24 | Class III | Error in labeling | Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Num | 47 | |
| 2018-11-07 | Class II | Employee error | Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS). | 3,667 units with software | 2022-07-14 |
| 2018-03-22 | Class II | Other | The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image. | 8 devices | 2021-04-28 |
| 2015-06-22 | Class II | Software design | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | Total of 4007 devices, all models | 2017-04-14 |
| 2015-06-22 | Class II | Software design | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | A total of 4007 devices, all models | 2017-04-14 |
| 2015-06-22 | Class II | Software design | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | A total of 4007 devices, all models | 2017-04-14 |
| 2015-06-22 | Class II | Software design | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | A total of 4007 devices, all models | 2017-04-14 |
| 2015-06-22 | Class II | Software design | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | A total of 4007 devices, all models | 2017-04-14 |
| 2015-06-22 | Class II | Software design | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. | A total of 4007 devices, all models | 2017-04-14 |
| 2013-09-23 | Class II | Nonconforming Material/Component | A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano’s sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano Syst | 227 total units – all models | 2015-07-09 |
| 2013-09-23 | Class II | Nonconforming Material/Component | A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano’s sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano Syst | 227 total units affected by the issue – all models | 2015-07-09 |
| 2013-09-23 | Class II | Nonconforming Material/Component | A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano’s sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano Syst | 227 total units – all models | 2015-07-09 |
| 2012-08-24 | Class II | Software design | The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself. | 1020 units | 2014-11-25 |
| 2010-06-29 | Not classified | Software design | Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may result in misdiagnosis and inappropriate t | 79 software kits | 2010-12-22 |
| 2010-06-11 | Not classified | Software design (manufacturing process) | Internal review of validation of pcMF Software kit found that instructions directs user to remove the rear panel, causing the potential for electric shock. | 8 units | 2012-02-07 |
| 2007-04-02 | Not classified | Other | During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility. | 351 units worldwide | 2008-06-03 |
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.