IPS
Cutting Guide, W/Planning, Recon, Complex, 00160, LP
16manufacturers in China registered for this device type
48catalogue numbers in this listing
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 | KLS-Martin L.P., United States |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2018-10-24 |
| Record revised | 2024-11-08 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60-001-60-09 | In distribution | |
| 60-002-21-09-LP | In distribution | |
| 60-001-63-09-LP | In distribution | |
| 60-002-83-09-LP | In distribution | |
| 60-008-53-09 | In distribution | |
| 60-008-67-09 | In distribution | |
| 60-002-23-09 | In distribution | |
| 60-001-63-09 | In distribution | |
| 60-002-82-09-LP | In distribution | |
| 60-004-05-09-LP | In distribution | |
| 60-004-01-09 | In distribution | |
| 60-002-25-09 | In distribution | |
| 60-004-10-09-LP | In distribution | |
| 60-000-12-09 | In distribution | |
| 60-002-86-09 | In distribution | |
| 60-004-13-09 | In distribution | |
| 60-004-02-09 | In distribution | |
| 60-002-24-09-LP | In distribution | |
| 60-000-13-09 | In distribution | |
| 60-004-05-09 | In distribution | |
| 60-008-30-09 | In distribution | |
| 60-004-38-09 | In distribution | |
| 60-002-86-09-LP | In distribution | |
| 60-004-02-09-LP | In distribution | |
| 60-004-01-09-LP | In distribution | |
| 60-002-25-09-LP | In distribution | |
| 60-001-97-09-PP | In distribution | |
| 60-002-87-09 | In distribution | |
| 60-500-01-09 | In distribution | |
| 60-002-88-09-PP | In distribution | |
| 60-002-88-09 | In distribution | |
| 60-001-96-09-LP | In distribution | |
| 60-004-06-09-LP | In distribution | |
| 60-004-06-09 | In distribution | |
| 60-004-12-09 | In distribution | |
| 60-004-11-09 | In distribution | |
| 60-500-14-09 | In distribution | |
| 60-004-38-09-PP | In distribution | |
| 60-004-10-09 | In distribution | |
| 60-004-36-09-PP | In distribution | |
| 60-002-22-09-LP | In distribution | |
| 60-002-83-09-PP | In distribution | |
| 60-002-20-09-LP | In distribution | |
| 60-011-41-09-LP | In distribution | |
| 60-001-60-09-LP | In distribution | |
| 60-011-01-09-LP | In distribution | |
| 60-002-83-09 | In distribution | |
| 60-000-14-09 | Withdrawn |
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 |
| 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 |
| VSP System | 3D Systems, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
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.