Radiological Computer-Assisted Triage And Notification Software
Radiology · 21 CFR 892.2080
Open FDA's page for this record- Third party flag
- N
- Life sustain support flag
- N
- Gmp exempt flag
- N
- Summary malfunction reporting
- Ineligible
- Product code
- QAS
- Review panel
- RA
- Medical specialty
- RA
- Device name
- Radiological Computer-Assisted Triage And Notification Software
- Medical specialty description
- Radiology
- Device class
- 2
- Regulation number
- 892.2080
- Implant flag
- N
- Submission type ID
- 1
- Definition
Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification .
- Harmonized identifiers (openFDA)
- K number
- K200873, K231384, K260906, K250685, K192167, K231025, K201020, K233968, K213721, K231767, K252421, K252366, K231837, K220709, K221314, K180647, K210209, K223240, K250248, K203260, K213886, K261085, K252970, K193087, K231094, K251533, K190424, K221716, K221248, K253818, K251983, K203508, K232496, K241719, K182875, K240942, K241480, K222329, K232751, K221456 +49 more
- Registration number
- 3021915828, 3021032044, 3017604664, 3014938447, 3017840913, 3014665798, 3015763655, 3016727312, 3011205675, 3035495311, 3017210169, 3007301305, 3023702863, 3012453401, 3034656245, 3014678441, 3017489096, 3004977335, 3038177848
- FEI number
- 3021915828, 3021032044, 3017604664, 3014938447, 3017840913, 3014665798, 3015763655, 3016727312, 3035495311, 3017210169, 3007301305, 3023702863, 3012453401, 3034656245, 3014678441, 3017489096, 3004977335, 3014269683, 3038177848