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Imagegrid Radiology Viewer System

FDA UDI

Class II (US FDA UDI)

by Candelis, Inc.

Identity

Trade Name
IMAGEGRID RADIOLOGY VIEWER SYSTEM FDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
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. FDA UDI
Model / Reference
IG-UHP-R1B FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
B193IGUHPR1B0 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiological PACS software

Imagegrid Radiology Viewer System by Candelis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Candelis, Inc.

Sources (1)

  • FDA UDI f66ac3b3-e76a-4c43-a576-041b74fdbd18 34 fields · synced Jun 8, 2026