iQ Flex

Primary DI
G221500MC0800
Brand
iQ Flex
Company
First Source, Inc.
Model
MD
Catalog number
500MC0800
Device description
This Mobile X-ray System (Model: iQFlex M/iQFlex MD) consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, and a collimator. A cart or a stand can be used with the iQFlex MD. The iQFlex M/iQFlex MD is used with a film-cassette or flat-panel detector.
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IZLSystem, X-Ray, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221081000iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray SystemFirst Source, Inc.2022-06-13IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G221500MC0800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray system generator, portableAn x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). This GMDN code includes transformer and inverter generator designs. Portable x-ray generators typically comprise a control assembly (console) and high voltage transformer assembly or are of a mono-tank generator design.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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G221100DRSTS0iQ Panorama1100DRSTS2023-06-12
G221100DRWBS0iQ Elevation1100DRWBS2023-06-12
G221500MC0740iQ Flex M500-MC-0742023-06-12

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Primary DI, Brand, Company table
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