510(k) K211803
K211803 is an FDA 510(k) premarket notification submitted by Zebra Medical Vision, Ltd. for the device "HealthPPT". The FDA issued a decision of Substantially Equivalent on Dec 15, 2021. The device falls under product code QFM (Radiological Computer-Assisted Prioritization Software For Lesions), a Class II device regulated under 21 CFR 892.2080. Zebra Medical Vision, Ltd. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 15, 2021
- Date Received
- Jun 11, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Computer-Assisted Prioritization Software For Lesions
- Device Class
- Class II
- Regulation Number
- 892.2080
- Review Panel
- RA
- Submission Type
- 510(k)
Radiological computer-assisted prioritization software for lesions 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.