Syngo.via
syngo.via VB20A "Stock Keeping Unit B" - product label DVD Media Cover "HF02": Unit contains following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional…
syngo.via VB20A “Stock Keeping Unit B” – product label DVD Media Cover “HF02”: Unit contains following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional -GTIN 04056869026305;(3) syngo.CT Coronary Analysis – GTIN 04056869026329;(4)syngo.CT Cardiac Function -GTIN 04056869026336;(5)syngo.CT CaScoring -GTIN 04056869026343;(6) syngo.CT Vascular Analysis -GTIN04056869026350;(7)syngo.CT Colonography -GTIN 04056869026367;(8)syngo.CT Pulmo3D -GTIN 04056869026374;(9)syng
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems 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 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological
Record
| Listed by | Siemens Healthcare Limited, Canada |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K150843 |
| Record published | 2017-08-18 |
| Record revised | 2023-12-04 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11299040 | In distribution | |
| 11298690 | In distribution | |
| 11298680 | In distribution | |
| 11298689 | In distribution | |
| 11298722 | In distribution | |
| 11298712 | In distribution | |
| 11250036 | In distribution | |
| 11582847 | In distribution | |
| 11368091 | In distribution | |
| 11250065 | In distribution | |
| 11299058 | In distribution | |
| 11249822 | In distribution | |
| 11461857 | In distribution | |
| 11461436 | In distribution | |
| 11250093 | In distribution | |
| 11299019 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imagegrid Radiology Viewer System | Candelis, Inc. | 173 |
| Tims System | Foresight Imaging, LLC | 159 |
| System, Image Processing, Radiological | Biomet Microfixation | 146 |
| RamSoft | Ramsoft, Inc. | 65 |
| Joints | Medstrat | 62 |
| OrthoView | Meridian Technique Ltd | 54 |
| IPS | KLS-Martin L.P. | 48 |
| NovaPACS | Novarad Corp. | 42 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 34 |
| DTX Studio™ Clinic | Nobel Biocare AB | 34 |
| Eaglesoft | Patterson Technology Center | 33 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252608 | 2025-09-09 |
| K240294 | 2024-05-23 |
| K232744 | 2023-12-21 |
| K230561 | 2023-03-21 |
| K230196 | 2023-02-13 |
| K221501 | 2022-10-14 |
| K213665 | 2022-06-21 |
| K201477 | 2020-07-01 |
| K191040 | 2019-05-16 |
| K182208 | 2018-09-07 |
| K180563 | 2018-04-25 |
| K173378 | 2017-11-20 |
| K171053 | 2017-06-01 |
| K161685 | 2016-07-11 |
| K150843 | 2015-04-24 |
| K132532 | 2013-12-09 |
| K123375 | 2012-11-20 |
| K043122 | 2005-02-09 |
| K992925 | 1999-11-23 |
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.