FDA.reportPublic FDA data

IntraX Film Processor

Primary DI
05060209580777
Brand
IntraX Film Processor
Company
MEDIVANCE INSTRUMENTS LIMITED
Model
MK6
Catalog number
I/MAC2016F
Published
2022-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IXWProcessor, Radiographic-Film, Automatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXWProcessor, Radiographic-Film, AutomaticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093503000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093503000INTRAX FILM PROCESSORVelopex International, Inc.2010-01-06IXW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060209580777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060209580777050602095807775060209580777

GMDN Terms#

Term, Definition table
TermDefinition
Dental automated x-ray film processorA mains electricity (AC-powered) automated dental x-ray film processor designed to be used in the dental practise for the rapid processing of films. This x-ray film processing system will automatically develop, fix, wash, and dry dental x-ray film. It is typically of floor or desktop design.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
228066353
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060209580012Velopex AquaCut Fluid Abrasion UnitMK5I/MAC8502F /I/MAC8503F /I/MAC8508F2022-08-06
05060209580814ExtraXtender Film ProcessorMK6I/MAC1017F2022-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060209580814ExtraXtender Film ProcessorMEDIVANCE INSTRUMENTS LIMITEDIXW2022-08-06
B580IWX0Mini MedAFP MANUFACTURING, INC.IXW2019-06-19
08809413810181Automatic Radiographic Film ProcessorJPI HEALTHCARE. CO., LTD.IXW2017-08-01
04260502640005COMPACT 2PROTEC GmbH & Co. KGIXW2016-10-28
04260502640012ECOMAXPROTEC GmbH & Co. KGIXW2016-10-28
04260502640029OPTIMAXPROTEC GmbH & Co. KGIXW2016-10-28
04260502640036OPTIMAX 2010PROTEC GmbH & Co. KGIXW2016-10-28
D678450000A/T 2000 XR Intraoral Film ProcessorAIR TECHNIQUES, INC.IXW2016-09-23
D678450040A/T 2000 XR Intraoral Film Processor with Water Recirculation SystemAIR TECHNIQUES, INC.IXW2016-09-23
D678940000Peri-Pro III Intraoral Film ProcessorAIR TECHNIQUES, INC.IXW2016-09-23