ImageMax

GUDID 00862879000303

Automatic X-Ray Film Processor

TATE TECHNOLOGY, INC.

Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor Dental automated x-ray film processor

• Primary Device ID: 00862879000303
• NIH Device Record Key: 604c0d66-4e78-45a5-b1f3-b108315b3186
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImageMax
• Version Model Number: 950
• Company DUNS: 789331063
• Company Name: TATE TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862879000303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992896

FDA Product Code

• EGY: Processor, Radiographic-Film, Automatic, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-01