PMA P980025S002

Device: LOGICON CARIES DETECTOR
Applicant: Carestream Dental, LLC
PMA number: P980025
Supplement: S002
Product code: MYN
Decision date: 2014-07-22
Classification: Analyzer, Medical Image
Generic name: Analyzer, medical image
Approval order statement: APPROVAL FOR THE ADDITION OF SOFTWARE MODULE PRESCAN TO LOGICON CARIES DETECTOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LOGICON CARIES DETECTOR AND HAS REVISED INDICATIONS FOR USE: THE LOGICON CARIES DETECTOR IS A SOFTWARE DEVICE THAT IS AN AID IN THE DIAGNOSIS OF CARIES THAT HAVE PENETRATED INTO THE DENTIN, ON UN-RESTORED PROXIMAL SURFACES OF SECONDARY DENTITION THROUGH THE STATISTICAL ANALYSIS OF DIGITAL INTRA-ORAL RADIOGRAPHIC IMAGERY. THE DEVICE PROVIDES ADDITIONAL INFORMATION FOR THE CLINICIAN TO USE IN HIS/HER DIAGNOSIS OF A TOOTH SURFACE SUSPECTED OF BEING CARIOUS. IT IS DESIGNED TO WORK IN CONJUNCTION WITH AN EXISTING CARESTREAM DENTAL RVG DIGITAL X-RAY RADIOGRAPHIC SYSTEM WITH DENTAL IMAGING SOFTWARE (DIS) FOR WINDOWS XP OR HIGHER.

Current openFDA PMA Record#

Device: LOGICON CARIES DETECTOR
Applicant: Carestream Dental, LLC
PMA number: P980025
Supplement: S002
Product code: MYN
Generic name: Analyzer, medical image
Decision date: 2014-07-22
Decision code: APPR
Date received: 2013-02-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF SOFTWARE MODULE PRESCAN TO LOGICON CARIES DETECTOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LOGICON CARIES DETECTOR AND HAS REVISED INDICATIONS FOR USE: THE LOGICON CARIES DETECTOR IS A SOFTWARE DEVICE THAT IS AN AID IN THE DIAGNOSIS OF CARIES THAT HAVE PENETRATED INTO THE DENTIN, ON UN-RESTORED PROXIMAL SURFACES OF SECONDARY DENTITION THROUGH THE STATISTICAL ANALYSIS OF DIGITAL INTRA-ORAL RADIOGRAPHIC IMAGERY. THE DEVICE PROVIDES ADDITIONAL INFORMATION FOR THE CLINICIAN TO USE IN HIS/HER DIAGNOSIS OF A TOOTH SURFACE SUSPECTED OF BEING CARIOUS. IT IS DESIGNED TO WORK IN CONJUNCTION WITH AN EXISTING CARESTREAM DENTAL RVG DIGITAL X-RAY RADIOGRAPHIC SYSTEM WITH DENTAL IMAGING SOFTWARE (DIS) FOR WINDOWS XP OR HIGHER.