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…

Registry build 21.09.26

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.

16manufacturers in China registered for this device type
173catalogue numbers in this listing
4510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code LLZ
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

Regulatory record for Imagegrid Radiology Viewer System
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

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 numbers for Imagegrid Radiology Viewer System
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

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer