Imagegrid Radiology Viewer System
The ImageGrid® PACS is a software system intended for professional use only, by prescription in United States. Diagnosis is not performed by the software but by Radiologists, Clinicians and…
The ImageGrid® PACS is a software system intended for professional use only, by prescription in United States. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. ImageGrid® is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). The device does not contact the patient, nor does it control any life sustaining devices. Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor of sufficient resolution and which meets other technical specifications reviewed and accepted by the FDA. ImageGrid® MammoTech Viewer, ImageGrid® Referring Physician Viewer, ASTRA® Lite, ASTRA® Plus and ASTRA® Mobile must not be used for primary image interpretation.
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 | Candelis, Inc., United States |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| Record published | 2018-09-14 |
| Record revised | 2023-10-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2018-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IG-LT1-R2H-SAAS-X | In distribution | |
| IG-9H-SAAS-X | In distribution | |
| IG-9H-SAAS | In distribution | |
| IG-LT1-R1H-DR | In distribution | |
| IG-3H-SAAS-X | In distribution | |
| IG-4B-DR | In distribution | |
| IG-9B | In distribution | |
| IG-6H-SAAS | In distribution | |
| IG-3B-DR | In distribution | |
| IG-LT1-R2H-3DV-SAAS | In distribution | |
| IG-8H-DR-SAAS-X | In distribution | |
| IG-LT1-R2H-DR-X | In distribution | |
| IG-LT1-R1H-SAAS-X | In distribution | |
| IG-5H-3DV-SAAS | In distribution | |
| IG-LT1-R1H-3DV-R-X | In distribution | |
| IG-9B-DR | In distribution | |
| IG-3H-3DV-SAAS-X | In distribution | |
| IG-5H | In distribution | |
| IG-5B | In distribution | |
| IG-3H-DR-SAAS-X | In distribution | |
| IMD-1B | In distribution | |
| IG-4H-SAAS-X | In distribution | |
| IG-2H-DR-SAAS | In distribution | |
| IG-LT1-R2H | In distribution | |
| IG-9H | In distribution | |
| IG-8H-SAAS | In distribution | |
| IG-UHP-R1H-R | In distribution | |
| IG-LT1-R2B-DR | In distribution | |
| IG-4H-3DV-SAAS-X | In distribution | |
| IG-LT1-R2H-3DV-R-X | In distribution | |
| IG-LT1-R2H-DR | In distribution | |
| IG-8H-3DV-SAAS-X | In distribution | |
| IG-LT1-R1H-X | In distribution | |
| IG-8H-3DV-SAAS | In distribution | |
| IG-9H-DR-X | In distribution | |
| IG-LT1-R2H-3DV-R | In distribution | |
| IG-UHP-R1B | In distribution | |
| IG-3H-DR-X | In distribution | |
| IG-8H-3DV | In distribution | |
| IG-2B | In distribution | |
| IG-6H-3DV-SAAS | In distribution | |
| IG-LT1-R1H-DR-SAAS | In distribution | |
| IG-UHP-R1H-R-X | In distribution | |
| IG-9H-DR-SAAS | In distribution | |
| IG-10H-SAAS | In distribution | |
| IG-2H-X | In distribution | |
| IG-10H-DR-X | In distribution | |
| IG-8H-DR | In distribution | |
| IG-6H-SAAS-X | In distribution | |
| IG-LT1-R2H-3DV-X | In distribution | |
| IG-4H-DR-SAAS | In distribution | |
| IG-UHP-R1H-R-SAAS-X | In distribution | |
| IMD-1 | In distribution | |
| IG-10H-DR | In distribution | |
| IG-LT1-R2H-3DV-SAAS-X | In distribution | |
| IG-5H-SAAS-X | In distribution | |
| IMD-2 | In distribution | |
| IG-6H-DR-X | In distribution | |
| IG-6H-DR-SAAS | In distribution | |
| IG-3H-3DV | In distribution | |
| IG-4H-SAAS | In distribution | |
| IG-UHP-R1H-R-SAAS | In distribution | |
| IG-2H-3DV-X | In distribution | |
| IG-LT1-R1B | In distribution | |
| IG-5B-DR | In distribution | |
| IG-6H-3DV | In distribution | |
| IG-LT1-R2H-DR-SAAS-X | In distribution | |
| IG-4H-DR | In distribution | |
| IG-2H-SAAS | In distribution | |
| IG-2H-DR | In distribution | |
| IG-LT1-R2H-3DV-R-SAAS | In distribution | |
| IG-EXP-2B | In distribution | |
| IG-3H-X | In distribution | |
| IG-4H-DR-SAAS-X | In distribution | |
| IG-8H | In distribution | |
| IMD-3B | In distribution | |
| IG-UHP-R1B-DR | In distribution | |
| IG-3H-SAAS | In distribution | |
| IG-10H-3DV-SAAS | In distribution | |
| IG-6B | In distribution | |
| IG-5H-3DV | In distribution | |
| IG-5H-3DV-X | In distribution | |
| IG-3H-DR | In distribution | |
| IG-8B | In distribution | |
| IG-10H-3DV-SAAS-X | In distribution | |
| IG-2H | In distribution | |
| IG-LT1-R2H-SAAS | In distribution | |
| IG-9H-X | In distribution | |
| IG-6H-DR | In distribution | |
| IG-9H-3DV-SAAS | In distribution | |
| IG-LT1-R2H-3DV | In distribution | |
| IG-10H-3DV-X | In distribution | |
| IG-5H-DR-SAAS-X | In distribution | |
| IG-LT1-R1B-DR | In distribution | |
| IG-6H | In distribution | |
| IG-4H-3DV | In distribution | |
| IG-LT1-R1H-3DV-R | In distribution | |
| IG-LT1-R1H-3DV-R-SAAS | In distribution | |
| IG-9H-3DV-X | In distribution | |
| IG-10B | In distribution | |
| IG-3H | In distribution | |
| IG-6H-DR-SAAS-X | In distribution | |
| IG-4H-3DV-SAAS | In distribution | |
| IG-4H-3DV-X | In distribution | |
| IG-9H-3DV-SAAS-X | In distribution | |
| IG-1B | In distribution | |
| IG-4H | In distribution | |
| IG-5H-3DV-SAAS-X | In distribution | |
| IG-EXP-2H | In distribution | |
| IG-10H-DR-SAAS | In distribution | |
| IG-LT1-R1H-DR-SAAS-X | In distribution | |
| IG-8H-3DV-X | In distribution | |
| IG-6H-3DV-X | In distribution | |
| IG-10H-3DV | In distribution | |
| IG-8H-DR-SAAS | In distribution | |
| IG-9H-DR-SAAS-X | In distribution | |
| IG-3H-DR-SAAS | In distribution | |
| IG-LT1-R1H | In distribution | |
| IG-5H-DR-X | In distribution | |
| IG-4H-DR-X | In distribution | |
| IG-LT1-R2H-DR-SAAS | In distribution | |
| IG-10B-DR | In distribution | |
| IG-5H-DR | In distribution | |
| IG-9H-DR | In distribution | |
| IG-8B-DR | In distribution | |
| IG-9H-3DV | In distribution | |
| IG-3B | In distribution | |
| IG-6H-X | In distribution | |
| IG-2H-SAAS-X | In distribution | |
| IG-10H-SAAS-X | In distribution | |
| IG-10H-X | In distribution | |
| IG-LT1-R1H-3DV-R-SAAS-X | In distribution | |
| IG-10H-DR-SAAS-X | In distribution | |
| IG-3H-3DV-SAAS | In distribution | |
| IG-8H-DR-X | In distribution | |
| IG-6B-DR | In distribution | |
| IG-8H-X | In distribution | |
| IG-6H-3DV-SAAS-X | In distribution | |
| IG-LT1-R1H-SAAS | In distribution | |
| IG-4B | In distribution | |
| IG-8H-SAAS-X | In distribution | |
| IG-3H-3DV-X | In distribution | |
| IG-2H-3DV-SAAS-X | In distribution | |
| IG-2B-DR | In distribution | |
| IG-LT1-R2H-3DV-R-SAAS-X | In distribution | |
| IG-2H-3DV | In distribution | |
| IG-2H-DR-SAAS-X | In distribution | |
| IG-5H-X | In distribution | |
| IG-5H-DR-SAAS | In distribution | |
| IG-LT1-R1H-DR-X | In distribution | |
| IG-LT1-R2H-X | In distribution | |
| IMD-2B | In distribution | |
| IG-5H-SAAS | In distribution | |
| IG-10H | In distribution | |
| IG-2H-3DV-SAAS | In distribution | |
| IG-LT1-R2B | In distribution | |
| IG-2H-DR-X | In distribution | |
| IG-4H-X | In distribution | |
| IG-LT1-R1H-3DV | Withdrawn | |
| IMD320-3B | Withdrawn | |
| IMD320-1B | Withdrawn | |
| IMD320-2B | Withdrawn | |
| IG-2B-TT | Withdrawn | |
| IG-3B-TT | Withdrawn | |
| IG-7H-3DV | Withdrawn | |
| IG-7B-TT | Withdrawn | |
| IG-7B | Withdrawn | |
| IG-4B-TT | Withdrawn | |
| IG-5B-TT | Withdrawn | |
| IG-7H-DR | Withdrawn | |
| IG-8B-TT | Withdrawn | |
| IG-7B-DR | Withdrawn | |
| IG-6B-TT | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| VSP System | 3D Systems, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262143 | 2026-07-23 |
| K111694 | 2011-09-15 |
| K092949 | 2009-10-08 |
| K080333 | 2008-02-22 |
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.