ImageMax

Primary DI: 00862879000303
Brand: ImageMax
Company: TATE TECHNOLOGY, INC.
Model: 950
Device description: Automatic X-Ray Film Processor
Published: 2016-11-01
Public version status: Update
Distribution status: Not in Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
Code	Name
EGY	Processor, Radiographic-Film, Automatic, Dental

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
EGY	Processor, Radiographic-Film, Automatic, Dental	Radiology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K992896	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K992896	000	DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)	Dental X-Ray Support Systems, Inc.	1999-09-03	EGY

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00862879000303	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00862879000303	00862879000303	862879000303	0862879000303

GMDN Terms#

Term, Definition table
Term	Definition
Dental automated x-ray film processor	A 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: 789331063
Device count: 1
Serial number: true