DR Suni 400-1243S

GUDID 00851067007033

Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the images, archiving, and electronic transmission of images.

SUNI MEDICAL IMAGING, INC.

General-purpose dental x-ray system application software

• Primary Device ID: 00851067007033
• NIH Device Record Key: 6f4a7b6f-03cf-4c04-93e3-2d4984fa12a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DR Suni
• Version Model Number: Advanced Imaging
• Catalog Number: 400-1243S
• Company DUNS: 180451106
• Company Name: SUNI MEDICAL IMAGING, 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 408-227-6698
• Email: support@suni.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851067007033 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by SUNI MEDICAL IMAGING, INC.

• 00851067007057 - SuniIQ: 2018-07-06 The SuniIQ Digital Radiography System is a semiconductor imaging device intended to acquire real time intra-oral dental radiogra
• 00851067007002 - SuniRay2: 2018-03-29 The SuniRay2 Digital Radiography System is a semiconductor imaging device intended to acquire real‐time intra‐oral dental ra
• 00851067007019 - SuniRay2: 2018-03-29 The SuniRay2 Digital Radiography System is a semiconductor imaging device intended to acquire real‐time intra‐oral dental ra
• 00851067007026 - Prof Suni: 2018-03-29 Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the i
• 00851067007033 - DR Suni: 2018-03-29Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the images, archiving, and electronic transmission of images.
• 00851067007033 - DR Suni: 2018-03-29 Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the i
• 00851067007040 - SuniIQ: 2018-03-29 The SuniIQ Digital Radiography System is a semiconductor imaging device intended to acquire real time intra-oral dental radiogra