Radlink Cassette

GUDID 00866389000181

The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray exposure and has a grid to absorb scattered radiation.This model is designed for 10"x12" plates.

RADLINK, INC.

Digital imaging cassette
Primary Device ID00866389000181
NIH Device Record Keybc0dbf40-6e71-4fcb-affd-120ecf321cfa
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadlink Cassette
Version Model NumberCAS1012
Company DUNS069190036
Company NameRADLINK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100866389000181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-21

On-Brand Devices [Radlink Cassette]

00866389000198The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray
00866389000181The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray

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