What is FDA product code LMD?

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions.

Radiology › Image Processing and StorageSystem, Digital Image Communications, Radiological

Radiology Information Systems, Inc.

Name: Radiology Information Systems, Inc.
Brand: Radiology Information Systems, Inc.

For use as a storage and display node on a DICOM 3.0 Network. It can receive, store, transmit and display images as a PACS application. In addition it can merge information from its…

Registry build 21.09.26

For use as a storage and display node on a DICOM 3.0 Network. It can receive, store, transmit and display images as a PACS application. In addition it can merge information from its keyboard with bitmap images from imaging devices to create DICOM 3.0 image files

6manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (4), Tianjin (1), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LMD
Manufacturer	City	Province	Registered as	Device types
Coretronic Projection (Kunshan) Corporation	Kunshan	Jiangsu	Contract manufacturer	3
AUO (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	1
Nanjing Jusha Display Technology Co., Ltd.	Nanjing	Jiangsu	Manufacturer	7
Barco (Suzhou) Healthcare Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	4
Beijing Visual Perception Intelligence Technology Co., Ltd.	Tianjin	Tianjin	Manufacturer	1
E-COM Technology Co., Ltd.	Beijing	Beijing	Manufacturer	1

Record

Regulatory record for Radiology Information Systems, Inc.
Listed by	Radiology Information Systems, Inc., United States
FDA product code	LMD
Device type	System, Digital Image Communications, Radiological
Device class	Class 1
Regulation	21 CFR 892.2020
Establishment	Manufacturer
Record published	2022-12-01
Record revised	2023-10-18 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Radiology Information Systems, Inc.
Catalogue number	Size	Status
RSVS		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Vitrea Advanced Visualization	Canon Medical Informatics, Inc.	34
Barco	Barco, Inc	27
RadiForce®	Eizo Corporation	23
Vitrea Read	Canon Medical Informatics A/S	19
Image Diagnostics, Inc	Image Diagnostics, Inc.	19
ScaleOR	NDS Surgical Imaging, LLC.	17
interWORKS	Avreo, Inc.	16
Vitrea View	Canon Medical Informatics, Inc.	14
Clinical review 2MP	Barco, Inc	11
Barco	Fimi SRL	10
Super Ulstar	Durico C&T, Inc.	9
VISIUSmatrix	Imris Imaging, Inc.	9

Showing 12 of 193. All products under System, Digital Image Communications, Radiological

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K970641	1997-05-02

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.