DEXIS 10 (DEXIS Imaging Suite) 1.008.7934

GUDID EKAV100879340

DEXIS LLC

Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software

• Primary Device ID: EKAV100879340
• NIH Device Record Key: 2833d196-ac29-44a1-9768-90dfc50fa217
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXIS 10 (DEXIS Imaging Suite)
• Version Model Number: 10
• Catalog Number: 1.008.7934
• Company DUNS: 019717844
• Company Name: DEXIS LLC
• 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
HIBCC	EKAV100879340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090431

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-31
• Device Publish Date: 2022-01-21

Devices Manufactured by DEXIS LLC

• EKAV100879340 - DEXIS 10 (DEXIS Imaging Suite): 2022-01-31
• EKAV100879340 - DEXIS 10 (DEXIS Imaging Suite): 2022-01-31
• EKAV101244750 - DEXIS™ Software: 2021-11-22 Software
• EKAV101289030 - DEXcam3™ intraoral cameras: 2021-11-22 Digital intraoral camera
• EKAV101289070 - DEXcam3™ intraoral cameras: 2021-11-22 Digital intraoral camera
• EKAV082250710 - DEXIS Platinum™ intraoral sensor: 2018-07-06 Digital intraoral sensor
• EKAV082250730 - DEXIS Platinum™ intraoral sensor: 2018-07-06 Digital intraoral sensor
• EKAV082250740 - DEXIS Platinum™ intraoral sensor: 2018-07-06 Digital intraoral sensor
• EKAV082251940 - DEXIS Platinum™ intraoral sensor: 2018-07-06 Digital intraoral sensor