FDA.reportPublic FDA data

iQ Elevation

Primary DI
G221100DRWBS0
Brand
iQ Elevation
Company
First Source, Inc.
Model
1
Catalog number
100DRWBS
Device description
A weight bearing stand that will allow a patient to be positioned for various U-Arm x-ray examinations of lower extremities.
Published
2023-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KXHCradle, Patient, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXHCradle, Patient, RadiologicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G221100DRWBS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological general body-part positionerA device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010620413
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G221200CA3080iQ ViewV5200-CA-3082023-06-13
G221500MC0800iQ Flex MD500MC08002023-06-13
G221100DRSTS0iQ Panorama1100DRSTS2023-06-12
G221500MC0740iQ Flex M500-MC-0742023-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850043319153Hyperfine Foam Back PadHyperfine Operations, Inc.KXH2026-05-26
07640178060753MultipadPearl Technology AGKXH2025-12-17
07640178060760PearlFitPearl Technology AGKXH2025-12-17
07640178060852PearlFitPearl Technology AGKXH2025-12-17
07640178060906PearlFitPearl Technology AGKXH2025-12-17
07640178060982ProFoamPearl Technology AGKXH2025-12-17
07640178060999ProFoamPearl Technology AGKXH2025-12-17
07640178061002ProFoamPearl Technology AGKXH2025-12-17
07640178061019ProFoamPearl Technology AGKXH2025-12-17
07640178061750ProFoamPearl Technology AGKXH2025-12-17
07640178061767ProFoamPearl Technology AGKXH2025-12-17
07640178061774ProFoamPearl Technology AGKXH2025-12-17
07640178061781ProFoamPearl Technology AGKXH2025-12-17
07640178061804ProBeltPearl Technology AGKXH2025-12-17
07640178061859ProFoamPearl Technology AGKXH2025-12-17
07640178061866ProFoamPearl Technology AGKXH2025-12-17
07640178061873ProFoamPearl Technology AGKXH2025-12-17
07640178061880ProFoamPearl Technology AGKXH2025-12-17
07640178061897ProBeltPearl Technology AGKXH2025-12-17
07640178061903ProFoamPearl Technology AGKXH2025-12-17
07640178061910ProFoamPearl Technology AGKXH2025-12-17
07640178062085ProFoamPearl Technology AGKXH2025-12-17
07640178062092ProFoamPearl Technology AGKXH2025-12-17
07640178062108ProFoamPearl Technology AGKXH2025-12-17
07640178062115ProFoamPearl Technology AGKXH2025-12-17
07640178062122ProFoamPearl Technology AGKXH2025-12-17
07640178062139ProFoamPearl Technology AGKXH2025-12-17
07640178062146ProFoamPearl Technology AGKXH2025-12-17
07640178062153ProFoamPearl Technology AGKXH2025-12-17
07640178062078pearltecPearl Technology AGKXH2025-07-28