FDA.reportPublic FDA data

QG-TV-IP-FM

Primary DI
60889976573341
Brand
QG-TV-IP-FM
Company
CARESTREAM HEALTH, INC.
Model
QG-TV-IP-FM
Catalog number
6573349
Device description
QG-TV10-IPF-MAT TECHVISION QS-550 DRX AT
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
LMDSystem, digital image communications, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889976573341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997657334160889976573341

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system computer, diagnostic, general-purposeA dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software used specifically to control and monitor the operation of a general-purpose medical x-ray system and associated image processing, display and analysis functions.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EPIS960010EpisurfViewEpisurf Operations ABLMD2026-03-17
07290018052402aiOSAIDOC MEDICAL LTDLMD2026-03-08
04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01
00850061871374IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.LMD2025-11-18
00850054590145interWORKSAvreo IncLMD2025-11-14
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
03770024341072Sonio Pro v3SONIOLMD2025-08-28
00850054590138interWORKSAvreo IncLMD2025-08-26
00628105001199Vitrea ReadCanon Medical Informatics A/SLMD2025-08-15
00818834028837MiiS Horus Endoscope Display System -Video BoxTRI-ANIM HEALTH SERVICES, INC.LMD2025-08-12
08800184000009I-Rapha ViewIRM IncLMD2025-08-01
00612479273597McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00612479277359McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00612479277366McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00850061871268IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.LMD2025-07-14
00850061871275IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.LMD2025-07-14
00850061871282IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.LMD2025-07-14
00850025268332Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-05-16
07649988969867OptiVu StreamerINCREMED AGLMD2025-04-24
00850054590121interWORKSAvreo IncLMD2025-04-22
00300021451554Lilly TogetherELI LILLY AND COMPANYLMD2025-04-17
00300021458553Lilly TogetherELI LILLY AND COMPANYLMD2025-04-17
05415334053717BarcoBarco NVLMD2025-04-14
05415334053724BarcoBarco NVLMD2025-04-14
05415334053731BarcoBarco NVLMD2025-04-14
05415334054059BarcoBarco NVLMD2025-04-14