DEN180005 is an FDA 510(k) submission for the OsteoDetect. This device is classified as a Radiological Computer Assisted Detection/diagnosis Software For Fracture (Class II - Special Controls, product code QBS).
Submitted by Imagen Technologies, Inc. (New York, US). The FDA issued a Not Cleared (DENG) decision on May 24, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2090. A Radiological Computer Assisted Detection And Diagnostic Software For Suspected Fracture Is An Image Processing Device Intended To Aid In The Detection, Localization, And/or Characterization Of Fracture On Acquired Medical Images (e.g. Radiography, Mr, Ct). The Device Detects, Identifies And/or Characterizes Fracture Based On Features Or Information Extracted From Images, And May Provide Information About The Presence, Location, And/or Characteristics Of The Fracture To The User. Primary Diagnostic And Patient Management Decisions Are Made By The Clinical User..
| 510(k) Number | DEN180005 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 05, 2018 |
| Decision Date | May 24, 2018 |
| Days to Decision | 108 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | QBS - Radiological Computer Assisted Detection/diagnosis Software For Fracture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2090 |
| Definition | A Radiological Computer Assisted Detection And Diagnostic Software For Suspected Fracture Is An Image Processing Device Intended To Aid In The Detection, Localization, And/or Characterization Of Fracture On Acquired Medical Images (e.g. Radiography, Mr, Ct). The Device Detects, Identifies And/or Characterizes Fracture Based On Features Or Information Extracted From Images, And May Provide Information About The Presence, Location, And/or Characteristics Of The Fracture To The User. Primary Diagnostic And Patient Management Decisions Are Made By The Clinical User. |