ScanX Classic View

GUDID E247G87000

DÜRR DENTAL SE

Dental computed radiography digital imaging scanner
Primary Device IDE247G87000
NIH Device Record Key887ab078-8151-43d0-a3b7-309c377491eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameScanX Classic View
Version Model NumberG8700
Company DUNS315563684
Company NameDÜRR DENTAL SE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE247G87000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-24
Device Publish Date2019-04-16

Devices Manufactured by DÜRR DENTAL SE

E247732480 - ScanX Barrier Envelope, 100 Pcs, Size 02023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).
E247732482 - ScanX Barrier Envelope, 300 Pcs, Size 22023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).
E247G8800 - ScanX Swift 2.02023-03-07 Dental Image Plate Scanner
E247G8900 - ScanX Swift View 2.02023-03-07 Dental Image Plate Scanner
E247E7300A10 - VisionX2022-04-04 VisionX version 3.0.x
E247A78610 - ProVecta 3D Prime Ceph2022-03-14 X-Ray System
E247J21101 - CamX Elara2022-03-14
E247J27111 - CamX Cam Interchangeable Head2022-03-14

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