Syngo Utrasound Breast Analysis
Catalogue number 11507859, listed by Siemens Medical Solutions USA, Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (4), Tianjin (1), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| AUO (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Nanjing Jusha Display Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 7 |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Beijing Visual Perception Intelligence Technology Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
| E-COM Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Siemens Medical Solutions USA, Inc., United States |
|---|---|
| FDA product code | LMD |
| Device type | System, Digital Image Communications, Radiological |
| Device class | Class 1 |
| Regulation | 21 CFR 892.2020 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-29 |
| Record revised | 2023-10-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11507859 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitrea Advanced Visualization | Canon Medical Informatics, Inc. | 34 |
| Barco | Barco, Inc | 27 |
| RadiForce® | Eizo Corporation | 23 |
| Vitrea Read | Canon Medical Informatics A/S | 19 |
| Image Diagnostics, Inc | Image Diagnostics, Inc. | 19 |
| ScaleOR | NDS Surgical Imaging, LLC. | 17 |
| interWORKS | Avreo, Inc. | 16 |
| Vitrea View | Canon Medical Informatics, Inc. | 14 |
| Clinical review 2MP | Barco, Inc | 11 |
| Barco | Fimi SRL | 10 |
| Super Ulstar | Durico C&T, Inc. | 9 |
| VISIUSmatrix | Imris Imaging, Inc. | 9 |
Showing 12 of 193. All products under System, Digital Image Communications, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K973131 | 1997-11-12 |
| K953552 | 1995-10-24 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2015-05-06 | Class II | Software design | A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching feature, leading to diagnosis delay. | 131 | 2016-08-17 |
| 2007-05-02 | Not classified | Other | System could crash and result in data loss. | 19 units | 2008-09-17 |
| 2003-07-03 | Not classified | Other | Potential error can occur with the 3D post processing options MPR, MIP, and VRT. | 159 units | 2006-10-03 |
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.