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510(k) Data Aggregation
K Number
K040486Device Name
MEDIPACS
Manufacturer
Date Cleared
2004-03-11
(15 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NEOBIT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MEDIPACS™is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Device Description
MEDIPACS™ handles and displays various objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. The system transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
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