VistaSoft Version 4.0.x

GUDID E2472110100003A20

Dental Imaging Software.

DÜRR DENTAL SE

General-purpose dental x-ray system application software
Primary Device IDE2472110100003A20
NIH Device Record Key4372f81c-f7f9-47ed-b373-11d18f7b3e19
Commercial Distribution StatusIn Commercial Distribution
Brand NameVistaSoft
Version Model Number2110100003
Catalog NumberVersion 4.0.x
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
HIBCCE2472110100003A20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-30
Device Publish Date2025-09-22

Devices Manufactured by DÜRR DENTAL SE

E2472110100003A20 - VistaSoft2025-09-30Dental Imaging Software.
E2472110100003A20 - VistaSoft2025-09-30 Dental Imaging Software.
E24721301004130 - VistaPosition Anterior2024-05-27
E24721301004140 - VistaPosition Posterior2024-05-27
E24721301004150 - VistaPosition Endo2024-05-27
E24721301004160 - VistaPosition Bitewing2024-05-27
E247G37101 - VistaPosition Anterior/ Posterior Kit Titanium2024-05-27
E247G38101 - VistaPosition Anterior/ Posterior Kit2024-05-27
E247732480 - ScanX Barrier Envelope, 100 Pcs, Size 02023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).

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