Diagnocat
DGNCT LLC · Model 1.0 · UDI-DI 00860010268063
Description
Diagnocat software is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucency on permanent teeth captured on maxillofacial Cone Beam CT images, only in patients where a dental professional determined such images to be necessary to evaluate possible dental abnormalities and where the dental professional has the appropriate knowledge and training to interpret and assess maxillofacial Cone Beam CT images. The device provides additional aid for the dental professional to use in their identification of periapical radiolucency. The device is not intended as a replacement for a complete dental professional’s review or their clinical judgment that considers other relevant information from the patient or other images or patient history. The system is to be used by professionally trained and licensed dental professionals. Diagnocat is indicated for use by dental professionals for the second-read of CBCT radiographs of permanent teeth in patients 22 years of age or older.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-06 | GA Industries | GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product release. |
| 2006-05-04 | Riverain Medical Group | The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0 |
| 2006-05-04 | Riverain Medical Group | The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0 |
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