FDA.reportPublic FDA data

ScanX Swift View

Primary DI
E247G85000
Brand
ScanX Swift View
Company
DÜRR DENTAL SE
Model
G8500
Published
2018-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K170733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170733000ScanX Intraoral ViewDuerr Dental AG2017-05-01MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E247G85000PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315563684
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E24721301003290VistaPosition AnteriorRWT01.1D121301003292026-03-13
E24721301003300VistaPosition PosteriorRWT01.4D121301003302026-03-13
E24721301003320VistaPosition EndoRWT01.3D121301003322026-03-13
E24721301003330VistaPosition BitewingRWT01.2D121301003332026-03-13
E24721301004130VistaPosition AnteriorRWT01.A121301004132024-05-17
E24721301004140VistaPosition PosteriorRWT01.4A121301004132024-05-17
E24721301004150VistaPosition EndoRWT01.3A121301004152024-05-17
E24721301004160VistaPosition BitewingRWT01.2A12024-05-17
E2472110100003A20VistaSoft2110100003Version 4.0.x2025-09-22
E247A7000580511HVE Air Protect XL Plus, gray (4 pcs)A7000580512021-11-02
E247A7000580611HVE Air Protect XL Plus, gray (1 pcs)A7000580612021-11-02
E247A7000590111HVE Air Protect XL, gray (20 pcs)A7000590112021-11-02
E247A7000590511HVE Air Protect XL, gray (5 pcs)A7000590512021-11-02
E247E7300VisionXE7300Version 4.0.x2019-12-05
E247E72000DBSWIN 5.11.0E72002016-09-21
E247E7200A0DBSWINE7200A2019-04-09
E247G36110Phosphor Storage Plate IDX S1G36112021-09-19
E247G36120Phosphor Storage Plate IDX S2G36122021-09-19
E247G36130Phosphor Storage Plate IDX S3G36132021-09-19
E247G36140Phosphor Storage Plate IDX S4G36142021-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011175704A2Z ImagingZINNOVI INC.MUH2026-06-05
00860011175711A2Z ImagingZINNOVI INC.MUH2026-06-05
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