Acuity Direct X-Ray Photon Detection

GUDID 00872320006457

An intraoral x-ray sensor that doesn't require a scintillator, but converts x-ray photons directly to a digital image.

CAO GROUP, INC.

Dental digital imaging sensor, intraoral
Primary Device ID00872320006457
NIH Device Record Key99e1a3a5-cedf-4636-b61f-e61ae55ad00b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcuity Direct X-Ray Photon Detection
Version Model Number005-00123
Company DUNS102422578
Company NameCAO GROUP, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-999-2635
Emailsupport@amdlasers.com
Phone866-999-2635
Emailsupport@amdlasers.com
Phone866-999-2635
Emailsupport@amdlasers.com
Phone866-999-2635
Emailsupport@amdlasers.com
Phone866-999-2635
Emailsupport@amdlasers.com
Phone866-999-2635
Emailsupport@amdlasers.com
Phone866-999-2635
Emailsupport@amdlasers.com
Phone866-999-2635
Emailsupport@amdlasers.com
Phone866-999-2635
Emailsupport@amdlasers.com
Phone866-999-2635
Emailsupport@amdlasers.com
Phone866-999-2635
Emailsupport@amdlasers.com
Phone866-999-2635
Emailsupport@amdlasers.com
Phone866-999-2635
Emailsupport@amdlasers.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100872320006457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-27
Device Publish Date2024-02-19

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

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

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