FDA.reportPublic FDA data

ScanX Fit (without battery)

Primary DI
D678D5000F0
Brand
ScanX Fit (without battery)
Company
AIR TECHNIQUES, INC.
Model
D5000F
Device description
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101289000SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QBAir Techniques, Inc.2010-08-03MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D678D5000F1PackageHIBCC1In Commercial Distribution
D678D5000F0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiography digital imaging scannerA laser or light-based optical unit designed to convert medical images originally captured on x-ray film or phosphor storage plate (PSP) into a digital format. Examples of this device include devices employing video frame grabbers, and scanners which use lasers or charge-coupled devices. Depending on the design, the digitized images can then be digitally transferred from location to location, archived, or used with other digital image processing, analysis or recording systems.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height14Inch
Length18Inch
Weight43Pound
Width15.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius54 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8002478324xx@xx.com

Regulatory Flags#

DUNS number
043835081
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D67821701006011VistaScan Ultra View Accessory Kit21701006012026-04-10
D678J1205E0ScanX Duo TouchJ1205EJ1200E2026-03-27
D678J1205R0ScanX Duo TouchJ1205RJ1200R2026-03-27
D678NES44000FlowStar E-standNES44002026-01-05
D678NES44001FlowStar E-standNES44002026-01-05
D678734701Plate Transfer Box734702025-09-05
D678AS50X0AirStarAS50X2025-04-25
D678AS50X1AirStarAS50X2025-04-25
D678AS70X0AirStarAS70X2025-04-25
D67821701005000VistaScan Ultra View21701005002023-04-21
D678J12050ScanX Duo TouchJ1205J12002023-04-21
D678732482K1ScanX Barrier Envelopes73248-2K2023-09-12
D6787324801ScanX Barrier Envelopes73248-02019-08-23
D678A63410"Provecta HD 16"" Center to Center Wall Mounting Plate"A63412023-07-11
D678A63890Provecta HD Single Post Mounting PlateA63892023-07-11
D678A63301Provecta HD 16" Center to Center Wall Mounting PlateA63412023-07-11
D678A63361Provecta HD Single Post Mounting PlateA63892023-07-11
D678AS1200AirStar Clinical Air CompressorAS1202023-06-14
D678AS120C0AirStar Clinical Air CompressorAS120C2023-06-14
D678AS600AirStar Clinical Air CompressorAS602023-06-14

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Primary DI, Brand, Company table
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08809394330906VIVIX-S 4386WVIEWORKS CO., LTD.MQB2026-07-16
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