FDA.reportPublic FDA data

QS-500

Primary DI
60889976573440
Brand
QS-500
Company
CARESTREAM HEALTH, INC.
Model
QS-500
Catalog number
6573448
Device description
QS-510 RADIOGRAPHC TUBE STAND 10FT TRACK
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IYBTube mount, x-ray, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYBTube Mount, X-Ray, DiagnosticRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889976573440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997657344060889976573440

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system tube support, floor standA floor stand is a hardware assembly with its related mechanical, electronic or software controls that form the structure used to mount, support and facilitate positioning of the x-ray tube assembly sub-system of either a diagnostic x-ray system, therapeutic x-ray system, or an x-ray system designed for use as a radiation therapy simulator. Typically mobile, some designs also support and coordinate the movement and positioning of a radiographic cassette or image receptor assembly with respect to the position of the x-ray tube, e.g., a C-arm assembly. It is considered to be a component of a x-ray system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793169512
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60889976579336Vita Flex CR SystemVita Flex CR System65793382019-08-03
60889976579343Vita Flex CR SystemVita Flex CR System65793462019-08-03
60889976579367Vita Flex CR SystemVita Flex CR System65793612019-08-03
60889978625925Carestream DRX-1 SystemCarestream DRX-1 System86259232023-07-21
60889978624768DRX-Compass X-ray SystemDRX-Compass X-ray System86247692023-06-28
00889978626487D-SpeedD-Speed86264832023-06-26
60889978818891Ultra-speedUltra-speed88188902023-06-26
60889976554104CARESTREAM DR Long Length Imaging StandCARESTREAM DR Long Length Imaging Stand65541092023-06-26
60889975950600Focus HD 35 DetectorFocus HD 35 DetectorAL47122023-06-24
60889975950617Focus HD 43 DetectorFocus HD 43 DetectorAL47132023-06-24
60889978626007DRX-Rise Mobile X-ray SystemDRX-Rise Mobile X-ray System86260042023-06-22
60889976701171CARESTREAM Image SuiteCARESTREAM Image Suite67011712022-02-25
60889971051264D-SpeedD-Speed10512672022-01-11
60889978624188DRX-Compass X-ray SystemDRX-Compass X-ray System86241812022-01-11
60889978624195DRX-Compass X-ray SystemDRX-Compass X-ray System86241992022-01-11
60889975950532DRX Plus 3543 DetectorDRX Plus 3543 DetectorAL67502021-09-04
60889975950549DRX Plus 3543C DetectorDRX Plus 3543C DetectorAL67552021-09-04
60889975950556DRX Plus 4343 DETECTORDRX Plus 4343 DETECTORAL67592021-09-04
60889975950563DRX Plus 4343C DETECTORDRX Plus 4343C DETECTORAL67642021-09-04
60889975950570Lux 35 DetectorLux 35 DetectorAK72942021-08-30

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Primary DI, Brand, Company table
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