AccessGUDID - DEVICE: arcc (00860002800301)

GUDID

Device Identifier (DI) Information

Brand Name: arcc
Version or Model: 01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APOLLO ENTERPRISE IMAGING CORP

Primary DI Number: 00860002800301
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828799853 *Terms of Use

Device Description: Apollo arcc® is a Health Information System facilitating the combination of patient information received from another information system (HL7 interface) with clinical multimedia (images, video, audio and other formats) and clinical information in a highly organized and secure environment. Patient information may also be entered directly into arcc. The workflow is representative of standard clinical specialties including but not limited to pathology, gastroenterology, dermatology, surgery, etc. Digital media can be imported via TCP/IP or via digital capture through direct connection to a modality device (Ex. would be a microscope mounted camera).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60723	Medical image management system	A computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PCÃ¢â‚¬â„¢s)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMD	System, Digital Image Communications, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bf23d806-3781-4d39-8df1-024678757cd4
Public Version Date: November 11, 2021
Public Version Number: 3
DI Record Publish Date: April 20, 2021