Product code SHN
- Device name
- Calibration Software For Radiology Displays
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.1940
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.
- Source
- FDA openFDA device classification dataset