Acuity Direct X-Ray Photon Detection

GUDID 00872320006464

Acuity Direct X-Ray Photon Detection sensor, which converts x-rays directly to a digital image without the use of a scintillator.

CAO GROUP, INC.

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• Primary Device ID: 00872320006464
• NIH Device Record Key: 79564cd9-def5-4f98-842d-ce1687f8c754
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acuity Direct X-Ray Photon Detection
• Version Model Number: 005-00214
• Company DUNS: 102422578
• Company Name: CAO GROUP, 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: true
• 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: 866-999-2635
• Email: support@amdlasers.com
• Phone: 866-999-2635
• Email: support@amdlasers.com
• Phone: 866-999-2635
• Email: support@amdlasers.com
• Phone: 866-999-2635
• Email: support@amdlasers.com
• Phone: 866-999-2635
• Email: support@amdlasers.com
• Phone: 866-999-2635
• Email: support@amdlasers.com
• Phone: 866-999-2635
• Email: support@amdlasers.com
• Phone: 866-999-2635
• Email: support@amdlasers.com
• Phone: 866-999-2635
• Email: support@amdlasers.com
• Phone: 866-999-2635
• Email: support@amdlasers.com
• Phone: 866-999-2635
• Email: support@amdlasers.com
• Phone: 866-999-2635
• Email: support@amdlasers.com
• Phone: 866-999-2635
• Email: support@amdlasers.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00872320006464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220277

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

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: 2024-02-27
• Device Publish Date: 2024-02-19

On-Brand Devices [Acuity Direct X-Ray Photon Detection]

• 00872320006464: Acuity Direct X-Ray Photon Detection sensor, which converts x-rays directly to a digital image w
• 00872320006457: An intraoral x-ray sensor that doesn't require a scintillator, but converts x-ray photons direct