FDA.reportPublic FDA data

Radlink Cassette

Primary DI
00866389000181
Brand
Radlink Cassette
Company
RADLINK, INC.
Model
CAS1012
Device description
"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."
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052938000CR-PROEradlink, Inc.2005-11-17MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866389000181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866389000181008663890001818663890001810866389000181

GMDN Terms#

Term, Definition table
TermDefinition
Digital imaging cassetteA device used in medical imaging applications to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic imaging x-ray system and a computed radiography scanner, in the process of producing a digital image of a patient radiation pattern.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
069190036
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864908000131Radlink PH GPS BracketPH BRACKET2019-06-21
00864908000148Radlink GPS Tablet/Monitor StandM STAND2019-06-21
00864908000162Radlink GPS TraumaGPS Trauma2019-06-21
00864908000100Radlink DR Tablet RetrofitDRRETRO2016-12-06
00864908000124Radlink GPS Tablet StandSTAND2018-01-31
00866389000105Radlink GPS 2200GPS22002016-09-21
00866389000129Radlink Wireless C-Arm KitC-Arm Kit2016-09-21
00866389000143Radlink DR Pro 2200DR22002016-09-21
00866389000150Radlink CR Pro 2200CR201-12016-09-21
00866389000198Radlink CassetteCAS14172016-09-21
00866389000167Radlink Laser Pro 16LP1002016-09-21
00864908000117Radlink PACSPACS-SW2017-01-24
00866389000112Radlink GPS Tablet 2200TABLET2016-09-21
00866389000136Radlink GPS Bucky CartBucky2016-09-21
00866389000174Radlink SensorSENSOR2016-09-21

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