FDA.reportPublic FDA data

DRYVIEW 5950 Laser Imaging System

Primary DI
60889971033840
Brand
DRYVIEW 5950 Laser Imaging System
Company
CARESTREAM HEALTH, INC.
Model
DRYVIEW 5950 Laser Imaging System
Catalog number
1033844
Device description
DRYVIEW 5950 LASER IMAGER, 110V
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LMCCamera, multi format, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMCCamera, Multi Format, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889971033840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997103384060889971033840

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic-imaging multiformat cameraA mains electricity (AC-powered) camera-based imaging unit, typically using laser scanning techniques, that is designed to capture digital images created using diagnostic imaging systems, e.g., computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), gamma camera or ultrasound, and to reproduce them in variable image formats on x-ray or radiographic film. This device usually has adjustments that allow the operator to determine how many images will be recorded on one film sheet (multi-formatting). This can be typically anywhere from 1 to 128 images in multiples of two which can be recorded onto a single sheet of film.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793169512
Device count
1
DM exempt
false
Premarket exempt
false
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
04547410431957DRYPIX SmartFUJIFILM CORPORATIONLMC2024-06-07
04560141950474DRYPRO MODEL 873KONICA MINOLTA, INC.LMC2022-07-06
60889976571002DRYVIEW 5950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2017-08-02
60889976559352DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2017-04-28
04560141932487DRYPRO SIGMAKONICA MINOLTA, INC.LMC2016-10-05
04560141932494DRYPRO SIGMAKONICA MINOLTA, INC.LMC2016-10-05
04560141945630DRYPRO SIGMA 2KONICA MINOLTA, INC.LMC2016-10-05
04560141945647DRYPRO SIGMA 2KONICA MINOLTA, INC.LMC2016-10-05
04560141921641DRYPRO MODEL 832KONICA MINOLTA, INC.LMC2016-09-19
04560141922686DRYPRO MODEL 832KONICA MINOLTA, INC.LMC2016-09-19
04560141923119DRYPRO MODEL 873KONICA MINOLTA, INC.LMC2016-09-19
04560141923126DRYPRO MODEL 873KONICA MINOLTA, INC.LMC2016-09-19
60889971020178DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889971046024DRYVIEW 5950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889971055378DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889971055392DRYVIEW 5950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889976559345DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889976559598DRYVIEW CHROMA Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889976563595DRYVIEW 6950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889976565445DRYVIEW 6950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
14547410080527FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
14547410080558FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
14547410080770FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
14547410080794FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
14547410142430FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
14547410142454FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410180060DRYPIX PlusFUJIFILM CORPORATIONLMC2016-09-16
04547410180077DRYPIX PlusFUJIFILM CORPORATIONLMC2016-09-16
04547410207699DRYPIX LiteFUJIFILM CORPORATIONLMC2016-09-16
04547410207743Magazine SFUJIFILM CORPORATIONLMC2016-09-16