K241083
- 510(k) number
- K241083
- Device name
- SIS System
- Applicant
- Surgical Information Sciences, Inc. MN · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-06-14
- Date received
- 2024-04-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K241083.pdf
Official FDA record: K241083
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.