Dentrix Ascend Imaging

GUDID 00864058000302

Web-based dental Picture Archiving and Communications System (PACS)

REALCLOUD IMAGING, INC.

Radiology PACS software

• Primary Device ID: 00864058000302
• NIH Device Record Key: 87ec88e8-d32e-4f4f-9ac1-f4bae877ae39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentrix Ascend Imaging
• Version Model Number: 1
• Company DUNS: 079879515
• Company Name: REALCLOUD 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864058000302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151438

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: 6
• Public Version Date: 2019-05-23
• Device Publish Date: 2016-10-31

Devices Manufactured by REALCLOUD IMAGING, INC.

• 00864058000302 - Dentrix Ascend Imaging: 2019-05-23Web-based dental Picture Archiving and Communications System (PACS)
• 00864058000302 - Dentrix Ascend Imaging: 2019-05-23 Web-based dental Picture Archiving and Communications System (PACS)
• 00864058000319 - Dentrix Smart Image: 2019-02-01 Dental Medical Device Data Systems (MDDS)
• 00864058000326 - RealCloud HD1: 2019-01-21 HDTV intraoral camera