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Radlink PACS

FDA UDI

Class II (US FDA UDI)

by Radlink, Inc.

Identity

Trade Name
Radlink PACS FDA UDI
Generic Name
Radiology picture archiving and communication system digital archive device FDA UDI
Device Name
The Radlink Picture Archiving and Communication System (PACS) is an external server for storage and retrieval of varying modality images and their corresponding information. FDA UDI
Model / Reference
PACS-SW FDA UDI
Description
The Radlink Picture Archiving and Communication System (PACS) is an external server for storage and retrieval of varying modality images and their corresponding information. FDA UDI

Identifiers

Primary DI / UDI-DI
00864908000117 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology picture archiving and communication system digital archive device 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

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiology picture archiving and communication system digital archive device

Radlink PACS by Radlink, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology picture archiving and communication system digital archive device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Radlink, Inc.

Sources (1)

  • FDA UDI ed193300-2b35-4a66-8bba-b7121c5477a8 33 fields · synced Jun 8, 2026