FDA.reportPublic FDA data

CRUXCAN

Primary DI
08800049600016
Brand
CRUXCAN
Company
CRUXELL Corp
Model
CRX-1000
Catalog number
CRX-1000
Published
2019-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MUHSystem, X-Ray, Extraoral Source, Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183637000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183637000Cruxcan (CRX-1000)Cruxell Corp.2019-02-12MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800049600016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800049600016088000496000168800049600016

GMDN Terms#

Term, Definition table
TermDefinition
Dental computed radiography digital imaging scannerA device/device assembly designed to be used with an analogue dental x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing. It consists of an image reader/scanner and may also include an exposure unit with imaging receptor (e.g., a cassette containing a plate), or additional supportive hardware (e.g., a printer). The image is acquired on a photostimulatable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner; this device is dedicated to dental use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694772082
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009306110Cleartooth Digital X-RayCLEARTOOTH ELECTRONICS, INC.MUH2026-05-27
08800011200060Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
D090101397120IXS S2 Kit, CT, US, FR-CADental Imaging Technologies CorporationMUH2026-05-12
D090101329460DEXIS IXS Size 1 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090101329470DEXIS IXS Size 2 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090800045720DEXIS Ti2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045730DEXIS IXS Size 1 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045750DEXIS IXS Size 2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045770DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045780DEXIS IXS Size 2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800045790DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045810DEXIS IXS S2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045830DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045840DEXIS Ti2 Kit - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045850IXS S1 Warranty Replacement - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045860IXS S1 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045870IXS S2 Warranty NEW KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045880IXS S2 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049760DEXIS Ti2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049770DEXIS IXS Size 1 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049790DEXIS Ti2 Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049800DEXIS Ti2 Sensor & Acc. Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049810DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049820DEXIS IXS Size 2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800457100DEXIS Ti2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
08800000500164Cocoon SoloDEXCOWIN CO., LTD.MUH2026-03-31
D678J1205E0ScanX Duo TouchAIR TECHNIQUES, INC.MUH2026-03-27